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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744847
• Other study ID #: MD-2012-010
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2012
• Last updated: December 6, 2012
• Start date: January 2005
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cholangitis
• Cholecystitis
• Pancreatitis

Intervention

Device:
• Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation

Locations

Country	Name	City	State
Korea, Republic of	Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital	Seoul	Yongsan-gu

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pancreatitis rate between DGT and TPS	We observation for the comlication upto 1 week after ERCP	upto 1 week	Yes
Primary	success rate between DGT and TPS	from October 2010 to August 2012	up to 22months	Yes
Secondary	median cannulation time between DGT and TPS	median time for precedure	during precedure time	Yes