Necrotizing PancreatitisNCT03115918
Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
A study testing Pancreatic Duct Stent Placement and No Pancreatic Duct Stent Placement in people with Necrotizing Pancreatitis and Walled Off Necrosis, run by AdventHealth at 1 site in United States.
Trial summary
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Necrotizing Pancreatitis, Walled Off Necrosis
- What is being tested?
- Pancreatic Duct Stent Placement and No Pancreatic Duct Stent Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2016to 3 Nov 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
- The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
- Absence of pancreatic fluid collection (defined as those > 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
- No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP
Who cannot join
- Age <19 years
- Unable to obtain consent for the procedure from either the patient or LAR
- Patients with acute interstitial pancreatitis, without pancreatic necrosis
- Patients with BISAP score ≤ 2
- Patients with pancreatic fluid collection > 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
- Patients with DPDS on cross-sectional imaging or ERCP
- Unable to safely undergo ERCP for any reason
- Failed cannulation during ERCP
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, 32803
About this study
Official title: Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
Read the detailed description
This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT.
- Conditions
- Necrotizing Pancreatitis, Walled Off Necrosis
- Being tested
- Pancreatic Duct Stent Placement, No Pancreatic Duct Stent Placement
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Duct Stent PlacementDevice
Patients will be randomly allocated to either treatment arm to have a PD stent placed.
No Pancreatic Duct Stent PlacementOther
Patients will be randomly allocated to either treatment arm and not receive PD placement.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Duct Stent Placement | Active comparator | Subject will have placement of either the Advanix or Cook Pancreatic Stent placed. Receives: Device: Pancreatic Duct Stent Placement |
| No Pancreatic Duct Stent Placement | Active comparator | Subject will not have a pancreatic Duct stent placed. Receives: Other: No Pancreatic Duct Stent Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of WON between the PD stent and no PD stent groups
The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP.
Measured: 4-6 weeks post-index ERCP
Secondary outcomes (9)
Rates of WON Intervention
Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions)
Measured: 6 weeks
Rates of DPDS
Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP)
Measured: 6 weeks
Number of patients with Adverse events
Incidence of procedure related adverse events
Measured: 6 weeks
Rates of additional interventions resulting from complications
Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis
Measured: 6 weeks
Number of patients with Acute pancreatitis
Clinical adverse events related to underlying acute pancreatitis
Measured: 6 weeks
Number of patients with Local complications
Clinical adverse events arising as a result of local complications of acute pancreatitis
Measured: 6 weeks
Number of patients with Systemic complications
Clinical adverse events arising as a result of systemic complications of acute pancreatitis
Measured: 6 weeks
Length of stay
Duration of hospitalization in days
Measured: 6 weeks
Cost
Total hospital costs in US Dollars
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start4 Aug 2016
- Primary completionJul 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Necrotizing PancreatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115918
- Sponsor's protocol ID
- 922733
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2017
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share individual participant data.
Publications
Yadav 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 23622135Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
PubMed 22885331Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Freeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660.
PubMed 23086243Garg PK, Madan K, Pande GK, Khanna S, Sathyanarayan G, Bohidar NP, Tandon RK. Association of extent and infection of pancreatic necrosis with organ failure and death in acute necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2005 Feb;3(2):159-66. doi: 10.1016/s1542-3565(04)00665-2.
PubMed 15704050Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PubMed 24054878Nadkarni NA, Kotwal V, Sarr MG, Swaroop Vege S. Disconnected Pancreatic Duct Syndrome: Endoscopic Stent or Surgeon's Knife? Pancreas. 2015 Jan;44(1):16-22. doi: 10.1097/MPA.0000000000000216.
PubMed 25493375van 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 20410514Casas M, Mora J, Fort E, Aracil C, Busquets D, Galter S, Jauregui CE, Ayala E, Cardona D, Gich I, Farre A. [Total enteral nutrition vs. total parenteral nutrition in patients with severe acute pancreatitis]. Rev Esp Enferm Dig. 2007 May;99(5):264-9. doi: 10.4321/s1130-01082007000500004. Spanish.
PubMed 17650935Gupta R, Patel K, Calder PC, Yaqoob P, Primrose JN, Johnson CD. A randomised clinical trial to assess the effect of total enteral and total parenteral nutritional support on metabolic, inflammatory and oxidative markers in patients with predicted severe acute pancreatitis (APACHE II > or =6). Pancreatology. 2003;3(5):406-13. doi: 10.1159/000073657. Epub 2003 Sep 24.
PubMed 14526151Louie BE, Noseworthy T, Hailey D, Gramlich LM, Jacobs P, Warnock GL. 2004 MacLean-Mueller prize enteral or parenteral nutrition for severe pancreatitis: a randomized controlled trial and health technology assessment. Can J Surg. 2005 Aug;48(4):298-306.
PubMed 16149365Petrov MS, Kukosh MV, Emelyanov NV. A randomized controlled trial of enteral versus parenteral feeding in patients with predicted severe acute pancreatitis shows a significant reduction in mortality and in infected pancreatic complications with total enteral nutrition. Dig Surg. 2006;23(5-6):336-44; discussion 344-5. doi: 10.1159/000097949. Epub 2006 Dec 12.
PubMed 17164546Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Yi F, Ge L, Zhao J, Lei Y, Zhou F, Chen Z, Zhu Y, Xia B. Meta-analysis: total parenteral nutrition versus total enteral nutrition in predicted severe acute pancreatitis. Intern Med. 2012;51(6):523-30. doi: 10.2169/internalmedicine.51.6685. Epub 2012 Mar 15.
PubMed 22449657Varadarajulu S, Noone T, Hawes RH, Cotton PB. Pancreatic duct stent insertion for functional smoldering pancreatitis. Gastrointest Endosc. 2003 Sep;58(3):438-41. doi: 10.1067/s0016-5107(03)00025-7.
PubMed 14528225
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis
- ClinicalTrials.gov ID
- NCT03115918
- Acronym / sponsor ID
- 922733
- Conditions
- Necrotizing Pancreatitis, Walled Off Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 14 Apr 2017 (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.
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
Detailed description
This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Duct Stent Placement | Active comparator | Device: Pancreatic Duct Stent PlacementSubject will have placement of either the Advanix or Cook Pancreatic Stent placed. |
| No Pancreatic Duct Stent Placement | Active comparator | Other: No Pancreatic Duct Stent PlacementSubject will not have a pancreatic Duct stent placed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 19 years
- The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
- The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
- Absence of pancreatic fluid collection (defined as those > 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
Key exclusion criteria (8 listed)
- Age <19 years
- Unable to obtain consent for the procedure from either the patient or LAR
- Patients with acute interstitial pancreatitis, without pancreatic necrosis
- Patients with BISAP score ≤ 2
- Patients with pancreatic fluid collection > 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
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 |
|---|---|---|
| Pancreatic Duct Stent PlacementPatients will be randomly allocated to either treatment arm to have a PD stent placed. | Device | Pancreatic Duct Stent Placement |
| No Pancreatic Duct Stent PlacementPatients will be randomly allocated to either treatment arm and not receive PD placement. | Other | No Pancreatic Duct Stent Placement |
Primary outcome
Incidence of WON between the PD stent and no PD stent groups
Time frame: 4-6 weeks post-index ERCP
The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP.
9 secondary outcomes
Rates of WON Intervention
Time frame: 6 weeks
Rates of DPDS
Time frame: 6 weeks
Number of patients with Adverse events
Time frame: 6 weeks
Rates of additional interventions resulting from complications
Time frame: 6 weeks
Number of patients with Acute pancreatitis
Time frame: 6 weeks
Number of patients with Local complications
Time frame: 6 weeks
Number of patients with Systemic complications
Time frame: 6 weeks
Length of stay
Time frame: 6 weeks
Cost
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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 22885331Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 23086243Freeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660.
- Background: PubMed 15704050Garg PK, Madan K, Pande GK, Khanna S, Sathyanarayan G, Bohidar NP, Tandon RK. Association of extent and infection of pancreatic necrosis with organ failure and death in acute necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2005 Feb;3(2):159-66. doi: 10.1016/s1542-3565(04)00665-2.
- Background: PubMed 24054878Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
- Background: PubMed 25493375Nadkarni NA, Kotwal V, Sarr MG, Swaroop Vege S. Disconnected Pancreatic Duct Syndrome: Endoscopic Stent or Surgeon's Knife? Pancreas. 2015 Jan;44(1):16-22. doi: 10.1097/MPA.0000000000000216.
- 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 17650935Casas M, Mora J, Fort E, Aracil C, Busquets D, Galter S, Jauregui CE, Ayala E, Cardona D, Gich I, Farre A. [Total enteral nutrition vs. total parenteral nutrition in patients with severe acute pancreatitis]. Rev Esp Enferm Dig. 2007 May;99(5):264-9. doi: 10.4321/s1130-01082007000500004. Spanish.
- Background: PubMed 14526151Gupta R, Patel K, Calder PC, Yaqoob P, Primrose JN, Johnson CD. A randomised clinical trial to assess the effect of total enteral and total parenteral nutritional support on metabolic, inflammatory and oxidative markers in patients with predicted severe acute pancreatitis (APACHE II > or =6). Pancreatology. 2003;3(5):406-13. doi: 10.1159/000073657. Epub 2003 Sep 24.
- Background: PubMed 16149365Louie BE, Noseworthy T, Hailey D, Gramlich LM, Jacobs P, Warnock GL. 2004 MacLean-Mueller prize enteral or parenteral nutrition for severe pancreatitis: a randomized controlled trial and health technology assessment. Can J Surg. 2005 Aug;48(4):298-306.
- Background: PubMed 17164546Petrov MS, Kukosh MV, Emelyanov NV. A randomized controlled trial of enteral versus parenteral feeding in patients with predicted severe acute pancreatitis shows a significant reduction in mortality and in infected pancreatic complications with total enteral nutrition. Dig Surg. 2006;23(5-6):336-44; discussion 344-5. doi: 10.1159/000097949. Epub 2006 Dec 12.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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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. This study is not recruiting at the moment.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic Duct Stent Placement and No Pancreatic Duct Stent Placement in people with Necrotizing Pancreatitis and Walled Off Necrosis, run by AdventHealth 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 6 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: finished, as of the sponsor's last update on 17 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of WON between the PD stent and no PD stent groups (time frame: 4-6 weeks post-index ERCP). 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 NCT03115918, which also lists 18 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 17 Feb 2022.