Pancreatic CystNCT04404101
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
A study testing 1). EUS-FNA plus MFB and 2). EUS-FNA Alone in people with Pancreatic Cyst, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- 1). EUS-FNA plus MFB and 2). EUS-FNA Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2021to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >18 years old
- Cysts > 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis
Who cannot join
- Age <18 years
- Inability to provide informed consent
- Thrombocytopenia (Platelets < 50,000) or coagulopathy (INR > 1.8)
- Pregnancy
- Post-surgical anatomy where the cyst is not accessible for FNA
- EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels)
- EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)
Trial locations and contacts
3 sites in 1 country.
Sandra Boimbo contact
United States3 sites, 3 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Sandra Boimbo, sandra.boimbo@cuanschutz.edu
Peter Tiley, peter.tiley@cuanschutz.edu
- Enrolling by invitation
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
University of California Irvine
Irvine, California, 92697
Jason Samarasena, MD, jsamaras@hs.uci.edu
Hailey Maxwell, maxwellh@hs.uci.edu
About this study
Official title: Evaluation of Pancreatic Cystic Lesions Via EUS-Guided Fine Needle Aspiration With and Without Micro Forceps Biopsies: A Multi-Center Prospective Randomized Study
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with fine needle aspiration (EUS-FNA) and sent for fluid analysis and cytology. More recently, the adjunctive use of the through-the-scope micro forceps (Moray micro forceps, US Endoscopy, Mentor, OH) biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.
Read the detailed description
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with FNA (Fine-Needle Aspiration) and sent for fluid analysis (CEA and amylase) and cytology. However, despite use of a cyst fluid carcinoembryonic antigen (CEA) level cutoff of 192 ng/mL and cytology, accuracy of diagnosis for PCLs is poor. As the spectrum ranges from benign to high risk for neoplasm, precise diagnosis is critical. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. Pancreatic cysts continue to pose a management dilemma for practicing clinicians, especially with the increased use of radiologic imaging modalities identifying incidental pancreatic cystic lesions with higher frequency. This leads to patient anxiety and increased costs due to radiologic surveillance and even surgery. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.
- Conditions
- Pancreatic Cyst
- Being tested
- 1). EUS-FNA plus MFB, 2). EUS-FNA Alone
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1). EUS-FNA plus MFBProcedure or surgery
The cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology.
2). EUS-FNA AloneProcedure or surgery
The cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology.
| Study group | Role | What they receive |
|---|---|---|
| 1). EUS-FNA plus MFB | Active comparator | A 19-G needle plus micro-forceps will be used for FNA plus MFB. Receives: Procedure: 1). EUS-FNA plus MFB |
| 2). EUS-FNA Alone | Active comparator | A 19-G needle will be used for FNA alone. Receives: Procedure: 2). EUS-FNA Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.
(1) Technical success will be defined as the ability to puncture the cyst with the FNA needle under EUS guidance, advance the micro forceps into the cyst to perform cyst biopsies and obtain a visible tissue fragment.
Measured: Intraprocedural
Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.
(2) Clinical success will be defined as the ability to obtain a pathologic tissue diagnosis (diagnostic yield) of the PCL with MFB. Based on prior experience, expected diagnoses include pseudocyst, serous cystadenoma, mucinous cyst (mucinous cystic neoplasm, intra-ductal papillary mucinous neoplasm), adenocarcinoma, and neuroendocrine tumor, to name a few.
Measured: 0-4 weeks
Safety of EUS-FNA plus MFB with that of EUS-FNA by recording adverse events per published ASGE (American Society for Gastrointestinal Endoscopy) criteria.
Intraprocedural and post-procedural adverse events (e.g. bleeding, infection, perforation, pancreatitis, etc.)
Measured: 0-4 Weeks
Secondary outcomes (2)
Technical ease in performing FNA and MFB
- Ease of passage of FNA needle
- Ease of passage of Micro Forceps
- Ease of EUS visualization of Micro Forceps Technical ease will be scored on a predetermined 5-point Likert scale (1 = best, 5 = worst)
Measured: Intraprocedural
Time taken for FNA and time for MFB
- Time for FNA will defined as time when FNA needle is introduced into the channel of the echoendoscope to the time cyst fluid is collected in the specimen tube/jar.
- Time for MFB will be defined as the time when micro forceps is introduced into the FNA needle for the first pass to the time when last tissue fragment is collected into the specimen jar after the last pass.
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start11 May 2021
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- US Endoscopy
- Responsible party
- Sponsor
- Investigators
- Anna Duloy, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404101
- Sponsor's protocol ID
- 18-1854
- Status last verified
- May 2024
- First submitted
- 21 May 2020
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moris M, Bridges MD, Pooley RA, Raimondo M, Woodward TA, Stauffer JA, Asbun HJ, Wallace MB. Association Between Advances in High-Resolution Cross-Section Imaging Technologies and Increase in Prevalence of Pancreatic Cysts From 2005 to 2014. Clin Gastroenterol Hepatol. 2016 Apr;14(4):585-593.e3. doi: 10.1016/j.cgh.2015.08.038. Epub 2015 Sep 11.
PubMed 26370569Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
PubMed 22687371Vege SS, Ziring B, Jain R, Moayyedi P; Clinical Guidelines Committee; American Gastroenterology Association. American gastroenterological association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. 2015 Apr;148(4):819-22; quize12-3. doi: 10.1053/j.gastro.2015.01.015. No abstract available.
PubMed 25805375Del Chiaro M, Verbeke C, Salvia R, Kloppel G, Werner J, McKay C, Friess H, Manfredi R, Van Cutsem E, Lohr M, Segersvard R; European Study Group on Cystic Tumours of the Pancreas. European experts consensus statement on cystic tumours of the pancreas. Dig Liver Dis. 2013 Sep;45(9):703-11. doi: 10.1016/j.dld.2013.01.010. Epub 2013 Feb 14.
PubMed 23415799Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013.
PubMed 15131794Attili F, Pagliari D, Rimbas M, Inzani F, Brizi MG, Costamagna G, Larghi A. Endoscopic ultrasound-guided histological diagnosis of a mucinous non-neoplastic pancreatic cyst using a specially designed through-the-needle microforceps. Endoscopy. 2016;48 Suppl 1:E188-9. doi: 10.1055/s-0042-108194. Epub 2016 May 23. No abstract available.
PubMed 27213974Mittal C, Obuch JC, Hammad H, Edmundowicz SA, Wani S, Shah RJ, Brauer BC, Attwell AR, Kaplan JB, Wagh MS. Technical feasibility, diagnostic yield, and safety of microforceps biopsies during EUS evaluation of pancreatic cystic lesions (with video). Gastrointest Endosc. 2018 May;87(5):1263-1269. doi: 10.1016/j.gie.2017.12.025. Epub 2018 Jan 6.
PubMed 29309781Zhang ML, Arpin RN, Brugge WR, Forcione DG, Basar O, Pitman MB. Moray micro forceps biopsy improves the diagnosis of specific pancreatic cysts. Cancer Cytopathol. 2018 Jun;126(6):414-420. doi: 10.1002/cncy.21988. Epub 2018 Apr 16.
PubMed 29660844Basar O, Yuksel O, Yang DJ, Samarasena J, Forcione D, DiMaio CJ, Wagh MS, Chang K, Casey B, Fernandez-Del Castillo C, Pitman MB, Brugge WR. Feasibility and safety of microforceps biopsy in the diagnosis of pancreatic cysts. Gastrointest Endosc. 2018 Jul;88(1):79-86. doi: 10.1016/j.gie.2018.02.039. Epub 2018 Mar 3.
PubMed 29510146Barresi L, Crino SF, Fabbri C, Attili F, Poley JW, Carrara S, Tarantino I, Bernardoni L, Giovanelli S, Di Leo M, Manfrin E, Tacelli M, Bruno MJ, Traina M, Larghi A. Endoscopic ultrasound-through-the-needle biopsy in pancreatic cystic lesions: A multicenter study. Dig Endosc. 2018 Nov;30(6):760-770. doi: 10.1111/den.13197. Epub 2018 Jul 5.
PubMed 29808529Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pancreatic Cystic Lesions Via EUS-Guided Fine Needle Aspiration With and Without Micro Forceps Biopsies: A Multi-Center Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04404101
- Acronym / sponsor ID
- 18-1854
- Conditions
- Pancreatic Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- US Endoscopy
- Study start
- 11 May 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 May 2020 (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 cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with fine needle aspiration (EUS-FNA) and sent for fluid analysis and cytology. More recently, the adjunctive use of the through-the-scope micro forceps (Moray micro forceps, US Endoscopy, Mentor, OH) biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.
Detailed description
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with FNA (Fine-Needle Aspiration) and sent for fluid analysis (CEA and amylase) and cytology. However, despite use of a cyst fluid carcinoembryonic antigen (CEA) level cutoff of 192 ng/mL and cytology, accuracy of diagnosis for PCLs is poor. As the spectrum ranges from benign to high risk for neoplasm, precise diagnosis is critical. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. Pancreatic cysts continue to pose a management dilemma for practicing clinicians, especially with the increased use of radiologic imaging modalities identifying incidental pancreatic cystic lesions with higher frequency. This leads to patient anxiety and increased costs due to radiologic surveillance and even surgery. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1). EUS-FNA plus MFB | Active comparator | Procedure: 1). EUS-FNA plus MFBA 19-G needle plus micro-forceps will be used for FNA plus MFB. |
| 2). EUS-FNA Alone | Active comparator | Procedure: 2). EUS-FNA AloneA 19-G needle will be used for FNA alone. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients >18 years old
- Cysts > 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis
Key exclusion criteria (7 listed)
- Age <18 years
- Inability to provide informed consent
- Thrombocytopenia (Platelets < 50,000) or coagulopathy (INR > 1.8)
- Pregnancy
- Post-surgical anatomy where the cyst is not accessible for FNA
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 |
|---|---|---|
| 1). EUS-FNA plus MFBThe cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology. | Procedure or surgery | 1). EUS-FNA plus MFB |
| 2). EUS-FNA AloneThe cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology. | Procedure or surgery | 2). EUS-FNA Alone |
Primary outcome
Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.
Time frame: Intraprocedural
(1) Technical success will be defined as the ability to puncture the cyst with the FNA needle under EUS guidance, advance the micro forceps into the cyst to perform cyst biopsies and obtain a visible tissue fragment.
Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.
Time frame: 0-4 weeks
(2) Clinical success will be defined as the ability to obtain a pathologic tissue diagnosis (diagnostic yield) of the PCL with MFB. Based on prior experience, expected diagnoses include pseudocyst, serous cystadenoma, mucinous cyst (mucinous cystic neoplasm, intra-ductal papillary mucinous neoplasm), adenocarcinoma, and neuroendocrine tumor, to name a few.
Safety of EUS-FNA plus MFB with that of EUS-FNA by recording adverse events per published ASGE (American Society for Gastrointestinal Endoscopy) criteria.
Time frame: 0-4 Weeks
Intraprocedural and post-procedural adverse events (e.g. bleeding, infection, perforation, pancreatitis, etc.)
2 secondary outcomes
Technical ease in performing FNA and MFB
Time frame: Intraprocedural
Time taken for FNA and time for MFB
Time frame: Intraprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 26370569Moris M, Bridges MD, Pooley RA, Raimondo M, Woodward TA, Stauffer JA, Asbun HJ, Wallace MB. Association Between Advances in High-Resolution Cross-Section Imaging Technologies and Increase in Prevalence of Pancreatic Cysts From 2005 to 2014. Clin Gastroenterol Hepatol. 2016 Apr;14(4):585-593.e3. doi: 10.1016/j.cgh.2015.08.038. Epub 2015 Sep 11.
- Background: PubMed 22687371Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
- Background: PubMed 25805375Vege SS, Ziring B, Jain R, Moayyedi P; Clinical Guidelines Committee; American Gastroenterology Association. American gastroenterological association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. 2015 Apr;148(4):819-22; quize12-3. doi: 10.1053/j.gastro.2015.01.015. No abstract available.
- Background: PubMed 23415799Del Chiaro M, Verbeke C, Salvia R, Kloppel G, Werner J, McKay C, Friess H, Manfredi R, Van Cutsem E, Lohr M, Segersvard R; European Study Group on Cystic Tumours of the Pancreas. European experts consensus statement on cystic tumours of the pancreas. Dig Liver Dis. 2013 Sep;45(9):703-11. doi: 10.1016/j.dld.2013.01.010. Epub 2013 Feb 14.
- Background: PubMed 15131794Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013.
- Background: PubMed 27213974Attili F, Pagliari D, Rimbas M, Inzani F, Brizi MG, Costamagna G, Larghi A. Endoscopic ultrasound-guided histological diagnosis of a mucinous non-neoplastic pancreatic cyst using a specially designed through-the-needle microforceps. Endoscopy. 2016;48 Suppl 1:E188-9. doi: 10.1055/s-0042-108194. Epub 2016 May 23. No abstract available.
- Background: PubMed 29309781Mittal C, Obuch JC, Hammad H, Edmundowicz SA, Wani S, Shah RJ, Brauer BC, Attwell AR, Kaplan JB, Wagh MS. Technical feasibility, diagnostic yield, and safety of microforceps biopsies during EUS evaluation of pancreatic cystic lesions (with video). Gastrointest Endosc. 2018 May;87(5):1263-1269. doi: 10.1016/j.gie.2017.12.025. Epub 2018 Jan 6.
- Background: PubMed 29660844Zhang ML, Arpin RN, Brugge WR, Forcione DG, Basar O, Pitman MB. Moray micro forceps biopsy improves the diagnosis of specific pancreatic cysts. Cancer Cytopathol. 2018 Jun;126(6):414-420. doi: 10.1002/cncy.21988. Epub 2018 Apr 16.
- Background: PubMed 29510146Basar O, Yuksel O, Yang DJ, Samarasena J, Forcione D, DiMaio CJ, Wagh MS, Chang K, Casey B, Fernandez-Del Castillo C, Pitman MB, Brugge WR. Feasibility and safety of microforceps biopsy in the diagnosis of pancreatic cysts. Gastrointest Endosc. 2018 Jul;88(1):79-86. doi: 10.1016/j.gie.2018.02.039. Epub 2018 Mar 3.
- Background: PubMed 29808529Barresi L, Crino SF, Fabbri C, Attili F, Poley JW, Carrara S, Tarantino I, Bernardoni L, Giovanelli S, Di Leo M, Manfrin E, Tacelli M, Bruno MJ, Traina M, Larghi A. Endoscopic ultrasound-through-the-needle biopsy in pancreatic cystic lesions: A multicenter study. Dig Endosc. 2018 Nov;30(6):760-770. doi: 10.1111/den.13197. Epub 2018 Jul 5.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cyst
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
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. This study is not recruiting at the moment.
Sandra Boimbo contact
Anna Duloy, MD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1). EUS-FNA plus MFB and 2). EUS-FNA Alone in people with Pancreatic Cyst, run by University of Colorado, Denver at 3 sites 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Duloy, MD (+13037248892, anna.duloy@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs. (time frame: Intraprocedural). The study lists 3 primary outcomes in all. 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 NCT04404101, which also lists 11 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 21 May 2024.