DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study

Soon Chun Hyang University

Status and phase: Completed; Phase 4

Conditions: Cholecystitis; Cholangitis; Pancreatitis

Treatments: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

Study type: Interventional

Funder types: Other

Identifiers

NCT01744847

MD-2012-010

Details and patient eligibility

About

In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.

Full description

This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.).

Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.

Enrollment: 111 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance

Exclusion criteria

• refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

DGT, Tracer Metro® Direct™ Wire Guide

Active Comparator group

Description:

Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide

Treatment:

Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

TPS, Tracer Hybrid® Wire Guides

Active Comparator group

Description:

trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides

Treatment:

Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide