An interventional study of Prophylactic endoscopic sphincterotomy in Acute Biliary Pancreatitis, sponsored by Semmelweis University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Semmelweis University · Not applicable, Interventional, and Prevention
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 92 is close to the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
evidence of AP based on the Atlanta criteria:
high probability of a biliary etiology:
Exclusion Criteria:
ERCP/ES is recommended by the guidelines (3)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Prophylactic endoscopic sphincterotomy
This study arm will follow a conservative treatment strategy, and no endoscopic procedures will be performed.
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.
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
Time frame: 1 year
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At 3, 6, 9, and 12 months.
All-cause mortality
Death from any cause during follow-up.
Time frame: At 3, 6, 9, and 12 months.
Acute cholecystitis
Incidence of acute cholecystitis (Tokyo Guidelines).
Time frame: 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
Time frame: 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.
Time frame: Peri-procedural.
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) will be available upon reasonable request to the study investigators after publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: It will be available from 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
Access criteria: Researchers with a methodologically sound proposal may request access to the de-identified IPD. Requests should be submitted to the corresponding author. Data will be shared after approval of the request and signing a data-sharing agreement, through secure institutional data transfer.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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