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

Launched by HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE · May 8, 2024

Keywords

ClinConnect Summary

Our working hypothesis is that endoscopic treatment with biliary sphincterotomy will reduce the number of biliopancreatic events compared to conservative treatment in patients with non-operable biliary acute pancreatitis (AP) due to a high surgical risk or in those patients who refuse surgery.

The primary aim is to assess the recurrence of the combined variable of biliopancreatic events (BPE) (biliary colic, cholangitis, choledocholithiasis, acute cholecystitis or AP) of the endoscopic sphincterotomy strategy during the follow-up time after diagnosis of AP of biliary origin in inoperable p...

Gender

ALL

Eligibility criteria

• 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 symptomatic choledocholithiasis) or previous biliary sphincterotomy.
• • Previous cholecystectomy
• • Actual use of ursodeoxycholic acid
• • Gastrointestinal tract anatomy altered by previous hepatobiliary or upper gastrointestinal surgery.
• • Inability to tolerate endoscopy sedation, perforation of the digestive tract or other contraindication to endoscopy.
• • Coagulopathy with uncorrectable International Normalized Ratio \> 1.5 or uncorrectable thrombocytopenia \< 50000/mm3.
• • Other concomitant diagnoses on admission (liver abscesses, biliopancreatic neoplasia, acute cholecystitis).
• • Hemodynamic instability.
• • Baseline ECOG ≥4