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

Prospective randomized trial comparing the incidence of adverse events between pure cut and endocut cutting modes employed in endoscopic sphincterotomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5d27tn
Enrollment
Unknown
Registered
2019-12-10
Start date
2019-10-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conditions with indication of retrograde endoscopic cholangiopancreatography (ERCP) with endoscopic papillotomy, such as choledocholithiasis (biliary ducts lithiasis)

Interventions

Retrograde endoscopic cholangiopancreatography (ERCP) with endoscopic sphincterotomy (papillotomy) to treat choledocolithiasis, obstructive neoplasms or benign biliary stricture. 550 patients sibmitte
Procedure/surgery
E04.210.120.850

Sponsors

Faculdade de Medicina da Universidade São Paulo
Lead Sponsor
Faculdade de Medicina da Universidade São Paulo
Collaborator

Eligibility

Age
No minimum to 100 Years

Inclusion criteria

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

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.)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).—

Countries

Brazil

Contacts

Public ContactMateus Funari

Faculdade de Medicina da Universidade São Paulo

mateusfunari@gmail.com+55-011-26616467

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 8, 2026