Pancreatic NecrosisNECTARNCT06553651
Necrosectomy With Cryotechnology for Accelerated Removal
A study testing Cryotechnology Necrosectomy Procedure in people with Pancreatic Necrosis and Acute Pancreatitis, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
Trial summary
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Necrosis, Acute Pancreatitis, Acute Pancreatic Necrosis
- What is being tested?
- Cryotechnology Necrosectomy Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years and above, inclusive of both males and females.
- Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
- Imaging indicative of ≥30% necrotic material within the pancreas.
- Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
- Subjects able to tolerate repeated endoscopic procedures.
- Capacity for providing informed consent.
- Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
Who cannot join
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Presence of documented Pseudoaneurysm > 1cm within the WOPN.
- Intervening gastric varices or unavoidable blood vessels within the access tract.
- Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
- Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
- Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele B. Ryan, MS, 6175258266, mryan@bwh.harvard.edu
Christopher C. Thompson, MD, MSc
About this study
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas.
For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
Read the detailed description
Acute pancreatitis is the most common gastrointestinal disease requiring acute hospital admission. Pancreatic necrosis, a serious complication of acute pancreatitis, is the irreversible death of pancreatic tissue and, in some cases, surrounding abdominal tissue. Worldwide, the incidence of acute pancreatitis ranges from 13 to 45 cases per 100,000 people per year, with a subset progressing to necrotizing pancreatitis. Approximately 5-10% of acute pancreatitis cases progress to this severe form, which carries a significant morbidity and mortality burden, with mortality rates escalating to as high as 32% in cases complicated by infection. The management of pancreatic necrosis is challenging and requires several therapeutic interventions to mitigate the high morbidity and mortality associated with this condition.
The treatment of pancreatic necrosis includes several therapeutic strategies, each with varying degrees of invasiveness, efficacy, and associated risks:
Surgical debridement: Traditionally, surgical debridement has been the cornerstone of treatment for pancreatic necrosis, with the goal of removing necrotic tissue. Although effective, this approach is associated with significant risks, including high morbidity and mortality rates, as high as 39% in some studies. Surgical debridement is a very invasive procedure and often not suitable for patients with severe pancreatitis and their often compromised health status.
Percutaneous Catheter Drainage (PCD): A less invasive alternative to surgery, PCD facilitates drainage of infected necrotic fluid collections. However, its effectiveness is limited by its inability to effectively remove solid necrotic debris. This limitation often requires additional interventions or procedures.
Endoscopic necrosectomy: This minimally invasive technique involves the endoscopic removal of necrotic tissue through the stomach or duodenum. Endoscopic necrosectomy, particularly when used in a step-up approach that may combine PCD with endoscopic drainage and debridement, has been shown to reduce morbidity compared to surgery. Despite the better outcome of the endoscopic technique, there is a gap in effective devices for necrotic tissue removal. Primarily, devices that are utilized include polypectomy snares, biliary baskets, food bolus nets (Roth nets), and forceps. As they are not designed for this indication, their use is often sophisticated and not always successful. As a result, fragmentation and removal as well as a complete debridement of the necrotic tissue is not always achieved, and multiple sessions are required. In a large multicenter trial in the United States, the total number of interventions ranged from 3.1 (immediate direct endoscopic necrosectomy DEN) to 3.9 (delayed DEN). This reflects a significant limitation in the current management of pancreatic necrosis and requires alternative approaches.
Cryotechnology:
In contrast to conventional methods, cryotechnology provides a method for obtaining large tissue samples by utilizing the Joule-Thompson effect for the production of extremely cold temperatures at the probe tip.This involves the internal flow of carbon dioxide (CO2) from a high pressure source to a small nozzle at the tip of the instrument where it expands. The gas expansion causes a large temperature drop (Joule-Thomson effect) and as a result, the surrounding instrument tip is cooled. The expanded gas is returned internally from the tip to the cryosurgical unit via the return tube.
This technology is widely available and used in endoscopy, particularly in the field of pulmonology. Cryoprobes are flexible endoscopic instruments that are currently available in different diameters, 1.1 mm, 1.7 mm, and 2.4 mm. The longstanding safety and efficacy profile have demonstrated results in the safe and efficient management of the following clinical applications, biopsy, extraction and devitalization. They are intended for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. Tissue samples obtained with this technique (cryoadhesion) have been shown to be heavier and larger than those obtained with conventional forceps.
Potential for Pancreatic Necrosis and Significance:
The successful implementation of cryotechnology for extraction suggests its potential applicability for pancreatic necrosectomy. The use of cryoprobes for minimally invasive endoscopic removal of necrotic pancreatic tissue may represent a novel approach that overcomes the limitations of existing strategies. The ability of cryotechnology to secure larger tissue samples without significant bleeding risks, coupled with its safety profile, provides an opportunity to improve the management of necrotizing pancreatitis. This study aims to investigate the safety, efficacy, and feasibility of cryoprobe use for the endoscopic removal of necrotic tissue, setting the stage for future clinical advances in the management of necrotizing pancreatitis.
- Conditions
- Pancreatic Necrosis, Acute Pancreatitis, Acute Pancreatic Necrosis, Necrosis, Necrosis Pancreas, Walled-Off Pancreatic Necrosis
- Being tested
- Cryotechnology Necrosectomy Procedure
- Keywords
- Direct Endoscopic Necrosectomy (DEN), Endoscopic Necrosectomy, Pancreatic Necrosectomy, Necrosectomy, Cryotherapy, Cryotechnology
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatitis, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotechnology Necrosectomy ProcedureDevice
Also called Cryotherapy
Subjects undergo necrosectomy with 1.7 mm flexible cryoprobes, either concurrently with stent placement or post-placement, at the Investigator's discretion. The cryoprobe will freeze the necrotic tissue and extracted en-bloc. A maximum of 4 cryotechnology procedures will be performed, with each procedure aiming for significant debris removal and clinical improvement of walled-off pancreatic necrosis (WOPN) symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Cryotechnology Necrosectomy Procedure | Experimental | Enrolled subjects will undergo direct endoscopic necrosectomy using 1.7 mm single use, flexible cryoprobes, aimed at effectively removing necrotic tissue within the pancreatic cavity. Receives: Device: Cryotechnology Necrosectomy Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
To evaluate the effectiveness of cryotechnology for the removal of necrotic pancreatic tissue. Achievement of at least 70% removal of necrotic debris from the pancreatic collection being treated, as determined by change in computed tomography (CT) evaluation from baseline to 21 days post-treatment.
Measured: Baseline, Follow-up Visit Day 21
Secondary outcomes (6)
Safety and Procedure-Related Adverse Events
To assess the safety profile of using cryotechnology for necrosectomy by monitoring the incidence of intraprocedure-related adverse events, including intracaviteal bleeding during the procedure, aspiration, septic event, and perforation, through follow-up day 21.
Measured: Procedure Day 0, Follow-up Visit Day 21
Mean Total Procedure Time
To determine the efficiency of cryotechnology for necrosectomy by measuring the mean total procedure time required to achieve at least a 70% reduction in necrosis. Time from first insertion of the cryoprobe into the endoscope to the end of its use (last extraction from the endoscope). The total procedure time for achieving clearance of necrosis will be assessed across all necrosectomy sessions for each patient.
Measured: Procedure Day 0, Reintervention (if needed)
Total Number of Reinterventions
To quantify the necessity for additional interventions by recording the total number of reinterventions per patient required to achieve treatment success.
Measured: From Procedure Day 0 through Follow-up Visit Day 21
Clinical Improvement within 72 Hours
To evaluate early clinical improvement, defined as observable patient recovery within 72 hours following the index intervention, improvement in Gastrointestinal Symptom Rating Scale (GSRS) and improvement in c-reactive protein (CRP) labs from baseline. GSRS is seven-point Likert-type scale with 1 being no symptoms, to 7 being worst possible symptoms.
Measured: Baseline, Procedure Day 0, up to 3 days post-procedure
Duration of Hospital Stay
To assess the impact of cryotechnology on the length of hospital stay, measured from the index intervention to discharge in days.
Measured: From Procedure Day 0 through date of discharge
Quality of Life (QOL)
Evaluate QoL improvement using the 12 question Short Form survey (SF-12) scores from baseline to 21 (+/- 7) days post-last cryo debridement. Scores range from 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: Baseline, Follow-up Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, single-center, open-label, prospective, single-arm clinical study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher C. Thompson, MD, MSc
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Sponsor-investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, MSc, Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553651
- Sponsor's protocol ID
- 2024P002218
- Acronym
- NECTAR
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
Publications
Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.
PubMed 29631305Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
PubMed 23622135Trikudanathan G, Wolbrink DRJ, van Santvoort HC, Mallery S, Freeman M, Besselink MG. Current Concepts in Severe Acute and Necrotizing Pancreatitis: An Evidence-Based Approach. Gastroenterology. 2019 May;156(7):1994-2007.e3. doi: 10.1053/j.gastro.2019.01.269. Epub 2019 Feb 15.
PubMed 30776347Pinto S, Bellizzi S, Badas R, Canfora ML, Loddo E, Spada S, Khalaf K, Fugazza A, Bergamini S. Direct Endoscopic Necrosectomy: Timing and Technique. Medicina (Kaunas). 2021 Nov 28;57(12):1305. doi: 10.3390/medicina57121305.
PubMed 34946249Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X. Epub 2023 Nov 18.
PubMed 37980922van Brunschot S, Hollemans RA, Bakker OJ, Besselink MG, Baron TH, Beger HG, Boermeester MA, Bollen TL, Bruno MJ, Carter R, French JJ, Coelho D, Dahl B, Dijkgraaf MG, Doctor N, Fagenholz PJ, Farkas G, Castillo CFD, Fockens P, Freeman ML, Gardner TB, Goor HV, Gooszen HG, Hannink G, Lochan R, McKay CJ, Neoptolemos JP, Olah A, Parks RW, Peev MP, Raraty M, Rau B, Rosch T, Rovers M, Seifert H, Siriwardena AK, Horvath KD, van Santvoort HC. Minimally invasive and endoscopic versus open necrosectomy for necrotising pancreatitis: a pooled analysis of individual data for 1980 patients. Gut. 2018 Apr;67(4):697-706. doi: 10.1136/gutjnl-2016-313341. Epub 2017 Aug 3.
PubMed 28774886Mohamadnejad M, Anushiravani A, Kasaeian A, Sorouri M, Djalalinia S, Kazemzadeh Houjaghan A, Gaidhane M, Kahaleh M. Endoscopic or surgical treatment for necrotizing pancreatitis: Comprehensive systematic review and meta-analysis. Endosc Int Open. 2022 Apr 14;10(4):E420-E428. doi: 10.1055/a-1783-9229. eCollection 2022 Apr.
PubMed 35433210American Society for Gastrointestinal Endoscopy Technology Committee; Saumoy M, Trindade AJ, Bhatt A, Bucobo JC, Chandrasekhara V, Copland AP, Han S, Kahn A, Krishnan K, Kumta NA, Law R, Obando JV, Parsi MA, Trikudanathan G, Yang J, Lichtenstein DR; American Society for Gastrointestinal Endoscopy Technology Committee Chair. Summary: endoscopic therapies for walled-off necrosis. Gastrointest Endosc. 2023 Jun;97(6):1001-1002. doi: 10.1016/j.gie.2023.02.008. Epub 2023 Apr 26. No abstract available.
PubMed 37115165van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.
PubMed 20410514Besselink MG, van Santvoort HC, Nieuwenhuijs VB, Boermeester MA, Bollen TL, Buskens E, Dejong CH, van Eijck CH, van Goor H, Hofker SS, Lameris JS, van Leeuwen MS, Ploeg RJ, van Ramshorst B, Schaapherder AF, Cuesta MA, Consten EC, Gouma DJ, van der Harst E, Hesselink EJ, Houdijk LP, Karsten TM, van Laarhoven CJ, Pierie JP, Rosman C, Bilgen EJ, Timmer R, van der Tweel I, de Wit RJ, Witteman BJ, Gooszen HG; Dutch Acute Pancreatitis Study Group. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]. BMC Surg. 2006 Apr 11;6:6. doi: 10.1186/1471-2482-6-6.
PubMed 16606471Yachimski P, Landewee CA, Campisano F, Valdastri P, Obstein KL. The waterjet necrosectomy device for endoscopic management of pancreatic necrosis: design, development, and preclinical testing (with videos). Gastrointest Endosc. 2020 Sep;92(3):770-775. doi: 10.1016/j.gie.2020.04.024. Epub 2020 Apr 22.
PubMed 32334018Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179. doi: 10.4103/eus.eus_108_17.
PubMed 29882517Giri M, Huang G, Puri A, Zhuang R, Li Y, Guo S. Efficacy and Safety of Cryobiopsy vs. Forceps Biopsy for Interstitial Lung Diseases, Lung Tumors, and Peripheral Pulmonary Lesions: An Updated Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Mar 10;9:840702. doi: 10.3389/fmed.2022.840702. eCollection 2022.
PubMed 35372452Wirsing L, Linzenbold W, Jaeger SU, Stahl P, Ott G, Leibold T, Enderle M, Albert J, Peveling-Oberhag J. A new tool for bile duct tissue sampling: ex vivo clinical evaluation of intraductal cryobiopsy for cholangioscopy. Endosc Int Open. 2022 Jun 10;10(6):E809-E814. doi: 10.1055/a-1797-8966. eCollection 2022 Jun.
PubMed 35692925Klein JT, Berger F, Linzenbold W, Jager L, Enderle MD, Bosmuller H, Mundhenk J, Schwentner C, Bolenz C. Cryobiopsy in the Upper Urinary Tract: Preclinical Evaluation of a Novel Device. Urology. 2019 Jan;123:273-279. doi: 10.1016/j.urology.2018.10.003. Epub 2018 Oct 9.
PubMed 30312669
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necrosectomy With Cryotechnology for Accelerated Removal
- ClinicalTrials.gov ID
- NCT06553651
- Acronym / sponsor ID
- NECTAR / 2024P002218
- Conditions
- Pancreatic Necrosis, Acute Pancreatitis, Acute Pancreatic Necrosis, Necrosis, Necrosis Pancreas, Walled-Off Pancreatic Necrosis
- Keywords
- Direct Endoscopic Necrosectomy (DEN), Endoscopic Necrosectomy, Pancreatic Necrosectomy, Necrosectomy, Cryotherapy, Cryotechnology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Christopher C. Thompson, MD, MScUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas.
For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
Detailed description
Acute pancreatitis is the most common gastrointestinal disease requiring acute hospital admission. Pancreatic necrosis, a serious complication of acute pancreatitis, is the irreversible death of pancreatic tissue and, in some cases, surrounding abdominal tissue. Worldwide, the incidence of acute pancreatitis ranges from 13 to 45 cases per 100,000 people per year, with a subset progressing to necrotizing pancreatitis. Approximately 5-10% of acute pancreatitis cases progress to this severe form, which carries a significant morbidity and mortality burden, with mortality rates escalating to as high as 32% in cases complicated by infection. The management of pancreatic necrosis is challenging and requires several therapeutic interventions to mitigate the high morbidity and mortality associated with this condition.
The treatment of pancreatic necrosis includes several therapeutic strategies, each with varying degrees of invasiveness, efficacy, and associated risks:
Surgical debridement: Traditionally, surgical debridement has been the cornerstone of treatment for pancreatic necrosis, with the goal of removing necrotic tissue. Although effective, this approach is associated with significant risks, including high morbidity and mortality rates, as high as 39% in some studies. Surgical debridement is a very invasive procedure and often not suitable for patients with severe pancreatitis and their often compromised health status.
Percutaneous Catheter Drainage (PCD): A less invasive alternative to surgery, PCD facilitates drainage of infected necrotic fluid collections. However, its effectiveness is limited by its inability to effectively remove solid necrotic debris. This limitation often requires additional interventions or procedures.
Endoscopic necrosectomy: This minimally invasive technique involves the endoscopic removal of necrotic tissue through the stomach or duodenum. Endoscopic necrosectomy, particularly when used in a step-up approach that may combine PCD with endoscopic drainage and debridement, has been shown to reduce morbidity compared to surgery. Despite the better outcome of the endoscopic technique, there is a gap in effective devices for necrotic tissue removal. Primarily, devices that are utilized include polypectomy snares, biliary baskets, food bolus nets (Roth nets), and forceps. As they are not designed for this indication, their use is often sophisticated and not always successful. As a result, fragmentation and removal as well as a complete debridement of the necrotic tissue is not always achieved, and multiple sessions are required. In a large multicenter trial in the United States, the total number of interventions ranged from 3.1 (immediate direct endoscopic necrosectomy DEN) to 3.9 (delayed DEN). This reflects a significant limitation in the current management of pancreatic necrosis and requires alternative approaches.
Cryotechnology:
In contrast to conventional methods, cryotechnology provides a method for obtaining large tissue samples by utilizing the Joule-Thompson effect for the production of extremely cold temperatures at the probe tip.This involves the internal flow of carbon dioxide (CO2) from a high pressure source to a small nozzle at the tip of the instrument where it expands. The gas expansion causes a large temperature drop (Joule-Thomson effect) and as a result, the surrounding instrument tip is cooled. The expanded gas is returned internally from the tip to the cryosurgical unit via the return tube.
This technology is widely available and used in endoscopy, particularly in the field of pulmonology. Cryoprobes are flexible endoscopic instruments that are currently available in different diameters, 1.1 mm, 1.7 mm, and 2.4 mm. The longstanding safety and efficacy profile have demonstrated results in the safe and efficient management of the following clinical applications, biopsy, extraction and devitalization. They are intended for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. Tissue samples obtained with this technique (cryoadhesion) have been shown to be heavier and larger than those obtained with conventional forceps.
Potential for Pancreatic Necrosis and Significance:
The successful implementation of cryotechnology for extraction suggests its potential applicability for pancreatic necrosectomy. The use of cryoprobes for minimally invasive endoscopic removal of necrotic pancreatic tissue may represent a novel approach that overcomes the limitations of existing strategies. The ability of cryotechnology to secure larger tissue samples without significant bleeding risks, coupled with its safety profile, provides an opportunity to improve the management of necrotizing pancreatitis. This study aims to investigate the safety, efficacy, and feasibility of cryoprobe use for the endoscopic removal of necrotic tissue, setting the stage for future clinical advances in the management of necrotizing pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, single-center, open-label, prospective, single-arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Cryotechnology Necrosectomy Procedure | Experimental | Device: Cryotechnology Necrosectomy ProcedureEnrolled subjects will undergo direct endoscopic necrosectomy using 1.7 mm single use, flexible cryoprobes, aimed at effectively removing necrotic tissue within the pancreatic cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 18 years and above, inclusive of both males and females.
- Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
- Imaging indicative of ≥30% necrotic material within the pancreas.
- Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
- Subjects able to tolerate repeated endoscopic procedures.
Key exclusion criteria (8 listed)
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Presence of documented Pseudoaneurysm > 1cm within the WOPN.
- Intervening gastric varices or unavoidable blood vessels within the access tract.
- Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotechnology Necrosectomy ProcedureAlso: CryotherapySubjects undergo necrosectomy with 1.7 mm flexible cryoprobes, either concurrently with stent placement or post-placement, at the Investigator's discretion. The cryoprobe will freeze the necrotic tissue and extracted en-bloc. A maximum of 4 cryotechnology procedures will be performed, with each procedure aiming for significant debris removal and clinical improvement of walled-off pancreatic necrosis (WOPN) symptoms. | Device | Cryotechnology Necrosectomy Procedure |
Primary outcome
Technical Success Rate
Time frame: Baseline, Follow-up Visit Day 21
To evaluate the effectiveness of cryotechnology for the removal of necrotic pancreatic tissue. Achievement of at least 70% removal of necrotic debris from the pancreatic collection being treated, as determined by change in computed tomography (CT) evaluation from baseline to 21 days post-treatment.
6 secondary outcomes
Safety and Procedure-Related Adverse Events
Time frame: Procedure Day 0, Follow-up Visit Day 21
Mean Total Procedure Time
Time frame: Procedure Day 0, Reintervention (if needed)
Total Number of Reinterventions
Time frame: From Procedure Day 0 through Follow-up Visit Day 21
Clinical Improvement within 72 Hours
Time frame: Baseline, Procedure Day 0, up to 3 days post-procedure
Duration of Hospital Stay
Time frame: From Procedure Day 0 through date of discharge
Quality of Life (QOL)
Time frame: Baseline, Follow-up Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 29631305Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.
- Background: PubMed 23622135Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
- Background: PubMed 30776347Trikudanathan G, Wolbrink DRJ, van Santvoort HC, Mallery S, Freeman M, Besselink MG. Current Concepts in Severe Acute and Necrotizing Pancreatitis: An Evidence-Based Approach. Gastroenterology. 2019 May;156(7):1994-2007.e3. doi: 10.1053/j.gastro.2019.01.269. Epub 2019 Feb 15.
- Background: PubMed 34946249Pinto S, Bellizzi S, Badas R, Canfora ML, Loddo E, Spada S, Khalaf K, Fugazza A, Bergamini S. Direct Endoscopic Necrosectomy: Timing and Technique. Medicina (Kaunas). 2021 Nov 28;57(12):1305. doi: 10.3390/medicina57121305.
- Background: PubMed 37980922Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X. Epub 2023 Nov 18.
- Background: PubMed 28774886van Brunschot S, Hollemans RA, Bakker OJ, Besselink MG, Baron TH, Beger HG, Boermeester MA, Bollen TL, Bruno MJ, Carter R, French JJ, Coelho D, Dahl B, Dijkgraaf MG, Doctor N, Fagenholz PJ, Farkas G, Castillo CFD, Fockens P, Freeman ML, Gardner TB, Goor HV, Gooszen HG, Hannink G, Lochan R, McKay CJ, Neoptolemos JP, Olah A, Parks RW, Peev MP, Raraty M, Rau B, Rosch T, Rovers M, Seifert H, Siriwardena AK, Horvath KD, van Santvoort HC. Minimally invasive and endoscopic versus open necrosectomy for necrotising pancreatitis: a pooled analysis of individual data for 1980 patients. Gut. 2018 Apr;67(4):697-706. doi: 10.1136/gutjnl-2016-313341. Epub 2017 Aug 3.
- Background: PubMed 35433210Mohamadnejad M, Anushiravani A, Kasaeian A, Sorouri M, Djalalinia S, Kazemzadeh Houjaghan A, Gaidhane M, Kahaleh M. Endoscopic or surgical treatment for necrotizing pancreatitis: Comprehensive systematic review and meta-analysis. Endosc Int Open. 2022 Apr 14;10(4):E420-E428. doi: 10.1055/a-1783-9229. eCollection 2022 Apr.
- Background: PubMed 37115165American Society for Gastrointestinal Endoscopy Technology Committee; Saumoy M, Trindade AJ, Bhatt A, Bucobo JC, Chandrasekhara V, Copland AP, Han S, Kahn A, Krishnan K, Kumta NA, Law R, Obando JV, Parsi MA, Trikudanathan G, Yang J, Lichtenstein DR; American Society for Gastrointestinal Endoscopy Technology Committee Chair. Summary: endoscopic therapies for walled-off necrosis. Gastrointest Endosc. 2023 Jun;97(6):1001-1002. doi: 10.1016/j.gie.2023.02.008. Epub 2023 Apr 26. No abstract available.
- Background: PubMed 20410514van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.
- Background: PubMed 16606471Besselink MG, van Santvoort HC, Nieuwenhuijs VB, Boermeester MA, Bollen TL, Buskens E, Dejong CH, van Eijck CH, van Goor H, Hofker SS, Lameris JS, van Leeuwen MS, Ploeg RJ, van Ramshorst B, Schaapherder AF, Cuesta MA, Consten EC, Gouma DJ, van der Harst E, Hesselink EJ, Houdijk LP, Karsten TM, van Laarhoven CJ, Pierie JP, Rosman C, Bilgen EJ, Timmer R, van der Tweel I, de Wit RJ, Witteman BJ, Gooszen HG; Dutch Acute Pancreatitis Study Group. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]. BMC Surg. 2006 Apr 11;6:6. doi: 10.1186/1471-2482-6-6.
- Background: PubMed 32334018Yachimski P, Landewee CA, Campisano F, Valdastri P, Obstein KL. The waterjet necrosectomy device for endoscopic management of pancreatic necrosis: design, development, and preclinical testing (with videos). Gastrointest Endosc. 2020 Sep;92(3):770-775. doi: 10.1016/j.gie.2020.04.024. Epub 2020 Apr 22.
- Background: PubMed 29882517Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179. doi: 10.4103/eus.eus_108_17.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher C. Thompson, MD, MSc principal investigator
Brigham and Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotechnology Necrosectomy Procedure in people with Pancreatic Necrosis and Acute Pancreatitis, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate (time frame: Baseline, Follow-up Visit Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553651, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.