Study comparing the incidence of complications between different cutting modalities in endoscopic biliary access

Not Applicable

Recruiting

• Conditions: Conditions with indication of retrograde endoscopic cholangiopancreatography (ERCP) with endoscopic papillotomy, such as choledocholithiasis (biliary ducts lithiasis); obstructive periampular tumors (neoplasms).; C06.130.120.250.174; K80.5

• Registration Number: RBR-5d27tn
• Lead Sponsor: Faculdade de Medicina da Universidade São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with indication for ERCP with papillary papillotomy without previous papillotomy
Older than 18 years
Agreement with the consent form
Selective cannulation of the biliary tract through the major duodenal papilla

Exclusion Criteria

Non-acceptance of the consent form
Previous papillotomy
Incorrigible coagulopathy
Need for cannulation of the biliary tract by advanced modalities: Fistula; Precut, transpancreatic sphincterotomy
Surgical history that does not allow endoscopic access to the biliary tract (Billroth II, Roux-en-Y gastrectomy, etc.)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: pancreatitis (diagnosis by amylase values greater than 3 times the reference value and clinical evaluation with new characteristic abdominal pain). It will be stratified by the Cotton criteria for post-ERCP acute pancreatitis.

Secondary Outcome Measures

Name	Time	Method
We will evaluate the following secondary outcomes: bleeding (serial hematimetric indices - bleeding will be considered to be a hemoglobin drop of at least 1g / dL or exteriorization such as melena, hematochezia or hematemesis), perforation (diagnosis by endoscopic visualization or clinical evaluation and pneumoperitoneum imaging if cholangitis (clinical evaluation with fever T > 37,8 degrees - and discharge of purulent bile secretion).