Acute Biliary PancreatitisPROSECCONCT07238296
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
A study testing Prophylactic endoscopic sphincterotomy in people with Acute Biliary Pancreatitis, run by Semmelweis University.
Trial summary
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Biliary Pancreatitis
- What is being tested?
- Prophylactic endoscopic sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2026to 1 Jul 2028
- 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
- adult patients (above 18 years)
- naïve papilla
- evidence of AP based on the Atlanta criteria:
- pain in the upper abdomen
- serum amylase or lipase concentration > 3 times the upper limit of normal
- imaging features of acute pancreatitis on abdominal imaging
Show all 11Show fewer
- high probability of a biliary etiology:
- gallstones or biliary sludge on imaging (any type)
- dilated common bile duct on imaging defined as > 8 mm in patients ≤ 75 years or > 10 mm in patients > 75 years
- abnormal liver enzymes (alanine aminotransferase [ALT] two times the upper limit of normal)
- patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction <40%, severe uncontrolled hypertension, chronic kidney disease stage four or five
Who cannot join
- previous cholecystectomy
- previous endoscopic sphincterotomy or pancreatobiliary stenting
- ERCP/ES is recommended by the guidelines (3)
- sign of cholangitis
- presence of CBD stone on any imaging
- signs of stone in endoscopic ultrasonography or magnetic resonance imaging in case of abnormal liver enzymes (persistently elevated ALT and aspartate aminotransferase (AST) with less than a 20% decrease over four days) or dilated CBD (defined as above)
Show all 11Show fewer
- chronic pancreatitis
- estimated life expectancy < 12 months
- ERCP is contraindicated, e.g. the procedure cannot be carried out safely due to the patient's comorbidities or physical status; high risk of bleeding or contraindication of the discontinuation of the anticoagulation therapy.
- ERCP is technically not feasible due to altered anatomy, e.g., total gastrectomy, Roux-en-Y gastric bypass anatomy
- pancreatobiliary malignancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Endoscopic Sphincterotomy in Patients Unfit for Cholecystectomy After an Acute Biliary Pancreatitis Episode - an Open-label, Two-armed, Randomized Controlled Trial
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).
Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.
A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.
- Conditions
- Acute Biliary Pancreatitis
- Being tested
- Prophylactic endoscopic sphincterotomy
- Keywords
- ERCP, prophylactic sphincterotomy, cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic endoscopic sphincterotomyProcedure or surgery
Participants in this arm will undergo prophylactic endoscopic sphincterotomy performed by experienced endoscopists, with all recommended preventive measures against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) applied according to international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic endoscopic sphincterotomy | Active comparator | Papillary cannulation and sphincterotomy techniques will be performed in adherence to the recommendations outlined in the ESGE (European Society of Gastrointestinal Endoscopy) guideline. All recommended measures for post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis prevention must be implemented, including the use of prophylactic pancreatic stents, rectal nonsteroidal anti-inflammatory drugs, and optimal hydration protocols where appropriate.
All rescue techniques may be utilized if necessary, in accordance with clinical judgment and guideline recommendations.
ERCP/ES (endoscopic sphincterotomy) will be performed by an experienced endoscopist, defined as someone who has performed more than 300 ERCPs in their lifetime and maintains a native papilla cannulation success rate of at least 90%.
If the ES cannot be performed during the initial ERCP, the number of further attempts is under the discretion of the endoscopist. Receives: Procedure: Prophylactic endoscopic sphincterotomy |
| Conservative treatment | No intervention | This study arm will follow a conservative treatment strategy, and no endoscopic procedures will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent pancreatobiliary events
Composite time-to-first-event endpoint including:
- cholangitis - Tokyo guidelines
- recurrent acute biliary pancreatitis - revised Atlanta criteria
- choledocholithiasis - imaging/ERCP confirmation
- cholangiogenic liver abscess - imaging plus clinical diagnosis
Measured: 1 year
Secondary outcomes (8)
Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)
Each component event will be reported separately as the number of participants experiencing the event during follow-up. Definitions: recurrent acute biliary pancreatitis (revised Atlanta criteria), cholangitis (Tokyo guidelines), choledocholithiasis (imaging/ERCP-confirmed bile duct stone), cholangiogenic liver abscess (imaging and clinical diagnosis).
Measured: At 3, 6, 9, and 12 months.
Length of hospitalization
The number of days from hospital admission until discharge, as determined by the treating physician based on clinical stability and institutional criteria. Results will be reported as days of hospitalization per participant, summarized using descriptive statistics (mean, median, interquartile range and standard deviation).
Measured: From enrollment to one month.
Pancreatobiliary events requiring intensive care unit admission
Number of pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess) resulting in intensive care unit admission. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
Measured: At 3, 6, 9, and 12 months.
Mortality associated with pancreatobiliary events
Deaths directly attributable to pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess), adjudicated by the study committee. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
Measured: At 3, 6, 9, and 12 months.
All-cause mortality
Death from any cause during follow-up.
Measured: At 3, 6, 9, and 12 months.
Acute cholecystitis
Incidence of acute cholecystitis (Tokyo Guidelines).
Measured: At 3, 6, 9, and 12 months.
Post-endoscopic retrograde cholangiopancreatography pancreatitis
Incidence of pancreatitis (revised Atlanta-criteria) following endoscopic retrograde cholangiopancreatography, with focus on moderate and severe cases
Measured: Peri-procedural.
Other endoscopic retrograde cholangiopancreatography-related complications
Incidence of adverse events related to endoscopic retrograde cholangiopancreatography, including bleeding, cholangitis, and perforation.
Complications will be defined according to clinical, laboratory, endoscopic, and imaging findings, and classified by severity based on the need for intervention, hospitalization, or prolonged recovery.
Measured: Peri-procedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start3 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Biliary PancreatitisStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio, stratified by participating centre, using randomly varying permuted blocks of sizes 2 and 4.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238296
- Sponsor's protocol ID
- NNGYK/34436-6/2025
- Acronym
- PROSECCO
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available upon reasonable request to the study investigators after publication.
Publications
Hajibandeh S, Jurdon R, Heaton E, Hajibandeh S, O'Reilly D. The risk of recurrent pancreatitis after first episode of acute pancreatitis in relation to etiology and severity of disease: A systematic review, meta-analysis and meta-regression analysis. J Gastroenterol Hepatol. 2023 Oct;38(10):1718-1733. doi: 10.1111/jgh.16264. Epub 2023 Jun 27.
PubMed 37366550Dedemadi G, Nikolopoulos M, Kalaitzopoulos I, Sgourakis G. Management of patients after recovering from acute severe biliary pancreatitis. World J Gastroenterol. 2016 Sep 14;22(34):7708-17. doi: 10.3748/wjg.v22.i34.7708.
PubMed 27678352Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
PubMed 27299638Vazquez-Lglesias JL, Gonzalez-Conde B, Lopez-Roses L, Estevez-Prieto E, Alonso-Aguirre P, Lancho A, Suarez F F, Nunes R. Endoscopic sphincterotomy for prevention of the recurrence of acute biliary pancreatitis in patients with gallbladder in situ: long-term follow-up of 88 patients. Surg Endosc. 2004 Oct;18(10):1442-6. doi: 10.1007/s00464-003-9185-7. Epub 2004 Aug 26.
PubMed 15791366Uomo G, Manes G, Laccetti M, Cavallera A, Rabitti PG. Endoscopic sphincterotomy and recurrence of acute pancreatitis in gallstone patients considered unfit for surgery. Pancreas. 1997 Jan;14(1):28-31. doi: 10.1097/00006676-199701000-00005.
PubMed 8981504da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.
PubMed 26460661Schreurs WH, Juttmann JR, Stuifbergen WN, Oostvogel HJ, van Vroonhoven TJ. Management of common bile duct stones: selective endoscopic retrograde cholangiography and endoscopic sphincterotomy: short- and long-term results. Surg Endosc. 2002 Jul;16(7):1068-72. doi: 10.1007/s00464-001-9104-8. Epub 2002 May 3.
PubMed 11984690Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
PubMed 30943551Tari E, Vincze A, Czako L, Sandru V, Laursen SB, Cadoni S, Brunacci M, Kiss M, Hegyi P, Eross B. Prophylactic endoscopic sphincterotomy in patients unfit for cholecystectomy after an acute biliary pancreatitis episode (PROSECCO): study protocol for an open-label, two-armed, randomised controlled trial. BMJ Open. 2026 Apr 27;16(4):e114897. doi: 10.1136/bmjopen-2025-114897.
PubMed 42044960
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Endoscopic Sphincterotomy in Patients Unfit for Cholecystectomy After an Acute Biliary Pancreatitis Episode - an Open-label, Two-armed, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07238296
- Acronym / sponsor ID
- PROSECCO / NNGYK/34436-6/2025
- Conditions
- Acute Biliary Pancreatitis
- Keywords
- ERCP, prophylactic sphincterotomy, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Nov 2025 (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.
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).
Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.
A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio, stratified by participating centre, using randomly varying permuted blocks of sizes 2 and 4.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic endoscopic sphincterotomy | Active comparator | Procedure: Prophylactic endoscopic sphincterotomyPapillary cannulation and sphincterotomy techniques will be performed in adherence to the recommendations outlined in the ESGE (European Society of Gastrointestinal Endoscopy) guideline. All recommended measures for post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis prevention must be implemented, including the use of prophylactic pancreatic stents, rectal nonsteroidal anti-inflammatory drugs, and optimal hydration protocols where appropriate. All rescue techniques may be utilized if necessary, in accordance with clinical judgment and guideline recommendations. ERCP/ES (endoscopic sphincterotomy) will be performed by an experienced endoscopist, defined as someone who has performed more than 300 ERCPs in their lifetime and maintains a native papilla cannulation success rate of at least 90%. If the ES cannot be performed during the initial ERCP, the number of further attempts is under the discretion of the endoscopist. |
| Conservative treatment | No intervention | –This study arm will follow a conservative treatment strategy, and no endoscopic procedures will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- adult patients (above 18 years)
- naïve papilla
- evidence of AP based on the Atlanta criteria:
- high probability of a biliary etiology:
- patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction <40%, severe uncontrolled hypertension, chronic kidney disease stage four or five
Key exclusion criteria (11 listed)
- previous cholecystectomy
- previous endoscopic sphincterotomy or pancreatobiliary stenting
- ERCP/ES is recommended by the guidelines (3)
- chronic pancreatitis
- estimated life expectancy < 12 months
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 |
|---|---|---|
| Prophylactic endoscopic sphincterotomyParticipants in this arm will undergo prophylactic endoscopic sphincterotomy performed by experienced endoscopists, with all recommended preventive measures against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) applied according to international guidelines. | Procedure or surgery | Prophylactic endoscopic sphincterotomy |
Primary outcome
Recurrent pancreatobiliary events
Time frame: 1 year
Composite time-to-first-event endpoint including: * cholangitis - Tokyo guidelines * recurrent acute biliary pancreatitis - revised Atlanta criteria * choledocholithiasis - imaging/ERCP confirmation * cholangiogenic liver abscess - imaging plus clinical diagnosis
8 secondary outcomes
Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)
Time frame: At 3, 6, 9, and 12 months.
Length of hospitalization
Time frame: From enrollment to one month.
Pancreatobiliary events requiring intensive care unit admission
Time frame: At 3, 6, 9, and 12 months.
Mortality associated with pancreatobiliary events
Time frame: At 3, 6, 9, and 12 months.
All-cause mortality
Time frame: At 3, 6, 9, and 12 months.
Acute cholecystitis
Time frame: At 3, 6, 9, and 12 months.
Post-endoscopic retrograde cholangiopancreatography pancreatitis
Time frame: Peri-procedural.
Other endoscopic retrograde cholangiopancreatography-related complications
Time frame: Peri-procedural.
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 2 Sep 2026.
- Background: PubMed 37366550Hajibandeh S, Jurdon R, Heaton E, Hajibandeh S, O'Reilly D. The risk of recurrent pancreatitis after first episode of acute pancreatitis in relation to etiology and severity of disease: A systematic review, meta-analysis and meta-regression analysis. J Gastroenterol Hepatol. 2023 Oct;38(10):1718-1733. doi: 10.1111/jgh.16264. Epub 2023 Jun 27.
- Background: PubMed 27678352Dedemadi G, Nikolopoulos M, Kalaitzopoulos I, Sgourakis G. Management of patients after recovering from acute severe biliary pancreatitis. World J Gastroenterol. 2016 Sep 14;22(34):7708-17. doi: 10.3748/wjg.v22.i34.7708.
- Background: PubMed 27299638Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
- Background: PubMed 15791366Vazquez-Lglesias JL, Gonzalez-Conde B, Lopez-Roses L, Estevez-Prieto E, Alonso-Aguirre P, Lancho A, Suarez F F, Nunes R. Endoscopic sphincterotomy for prevention of the recurrence of acute biliary pancreatitis in patients with gallbladder in situ: long-term follow-up of 88 patients. Surg Endosc. 2004 Oct;18(10):1442-6. doi: 10.1007/s00464-003-9185-7. Epub 2004 Aug 26.
- Background: PubMed 8981504Uomo G, Manes G, Laccetti M, Cavallera A, Rabitti PG. Endoscopic sphincterotomy and recurrence of acute pancreatitis in gallstone patients considered unfit for surgery. Pancreas. 1997 Jan;14(1):28-31. doi: 10.1097/00006676-199701000-00005.
- Background: PubMed 26460661da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.
- Background: PubMed 11984690Schreurs WH, Juttmann JR, Stuifbergen WN, Oostvogel HJ, van Vroonhoven TJ. Management of common bile duct stones: selective endoscopic retrograde cholangiography and endoscopic sphincterotomy: short- and long-term results. Surg Endosc. 2002 Jul;16(7):1068-72. doi: 10.1007/s00464-001-9104-8. Epub 2002 May 3.
- Background: PubMed 30943551Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
- Derived from this study: PubMed 42044960Tari E, Vincze A, Czako L, Sandru V, Laursen SB, Cadoni S, Brunacci M, Kiss M, Hegyi P, Eross B. Prophylactic endoscopic sphincterotomy in patients unfit for cholecystectomy after an acute biliary pancreatitis episode (PROSECCO): study protocol for an open-label, two-armed, randomised controlled trial. BMJ Open. 2026 Apr 27;16(4):e114897. doi: 10.1136/bmjopen-2025-114897.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available upon reasonable request to the study investigators after publication.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic endoscopic sphincterotomy in people with Acute Biliary Pancreatitis, run by Semmelweis University.
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Balint Eross, MD, PhD (+36308874028, dr.eross.balint@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent pancreatobiliary events (time frame: 1 year). 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 NCT07238296, which also lists 9 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 2 Sep 2026.