DGT Versus TPS in Patients With Initial PD Cannulation by Chance;

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01744847
Study type	Interventional
Source	Soon Chun Hyang University
Contact
Status	Completed
Phase	Phase 4
Start date	January 2005
Completion date	August 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms