By InvitationNot Applicable

PrEveNtion of Biliary Events After Acute Pancreatitis in NonSUrgicaL PAtients: PENINSULA Trial

Spain126 participantsStarted 2024-12-16

Plain-language summary

Acute pancreatitis (AP) is a common condition and its main etiology is biliary. Cholecystectomy is the standard preventive treatment for recurrence of AP after admission. However, due to an increasingly older population and increased patient comorbidity, it is not always a possible option these days. If cholecystectomy is not performed, there is a significant risk for a recurrence of a biliopancreatic event (pancreatitis, biliary colic, choledocholithiasis, cholecystitis or cholangitis) of around 50% in the first year. This can lead to further episodes of pain, patient readmissions, and a reduced quality of life. Additionally, frequent readmissions can create a high cost burden on the health system. Currently, certain clinical guidelines propose biliary sphincterotomy as an alternative for patients in whom surgery is not feasible. However, this recommendation is based on retrospective studies with small sample size and the adherence to this recommendation is very low (12-23%). The goal of this clinical trial is to evaluate the recurrence of biliopancreatic events in the first year after admission for an acute biliary pancreatitis episode in patients that are not suitable for surgery. The main question it aims to answer is: Does biliary sphincterotomy prevent biliopancreatic event recurrence in non surgical patients after an episode of biliary acute pancreatitis? Researchers will compare biliary sphincterotomy vs conservative treatment to see if there is a reduction in biliopancreatic events during the first year after admission for acute pancreatitis in non surgical patients. Participants will be randomized to conservative treatment or biliary sphincterotomy and will be followed up for one year at 1 month, 6 months and 12 months to evaluate recurrence of BPE, readmissions, quality of life and mortality. Security of the technique will also be assessed in this specific population.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient older than 18 years old. * Definitive diagnosis of acute pancreatitis according to the presence of two out of three criteria from the Revised Atlanta Classification. At least 2 criteria: A) Typical pain, B) Amylase or lipase ≥x3 normal limit, C) Imaging evidence compatible with acute pancreatitis). * Biliary etiology: (any imaging test that describes gallbladder lithiasis/microlithiasis or biliary sludge). * Magnetic resonance cholangiography (MRCP) or endoscopic ultrasound (EUS) is required without evidence of choledocholithiasis. * Surgical decision of inoperable patient (if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index \> 5 and/or Karnofsky \< 50 or patient's decision not to undergo surgery. Patient must have been evaluated by general surgery or anesthesia. * Signature of the informed consent for the study Exclusion Criteria: * Patient refusal to participate in the study. * Active ethylism greater than or equal to 5 drinking units per day in men and 3 in women or strong clinical suspicion of clinically significant ethylism that could be a cause of their AP. * Hypertriglyceridemia greater than 400 mg/dl at admission or history of poorly controlled hypertriglyceridemia. * Chronic pancreatitis: pancreatic calcifications in body or Wirsung on imaging or Wirsung ≥ 4 mm * Biliary condition requiring sphincterotomy during index admission (cholangitis or…

What they're measuring

Biliopancreatic events (BPE)

Timeframe: From enrollment until 12 months after

Trial details

NCT IDNCT06409741

SponsorHospital General Universitario de Alicante

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Acute Pancreatitis Due to Gallstones trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.