NCT01745978

Brief Summary

The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

December 6, 2012

Last Update Submit

December 7, 2012

Conditions

Endoscopic Retrograde CholangiopancreatographyBile Duct Diseases

Outcome Measures

Primary Outcomes (1)

  • Successful biliary cannulation rate after precut papillotomy

    During endoscopic retrograde cholangiopancreatography (ERCP) procedure

Secondary Outcomes (1)

  • Biliary cannulation time after precut papillotomy

    From precut papillotomy started to biliary cannulation achieved or abandoned

Other Outcomes (1)

  • The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation

    7 days after ERCP

Study Arms (2)

the knob-tipped knife

EXPERIMENTAL

the knob-tipped knife using for precut papillotomy in difficult CBD cannulation

Procedure: Precut papillotomy

the needle knife

ACTIVE COMPARATOR

the needle knife using for precut papillotomy in difficult CBD cannulation

Procedure: Precut papillotomy

Interventions

Precut papillotomyPROCEDURE
the knob-tipped knifethe needle knife

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intact papilla and deep cannulation of the bile duct
  • a standard wire-guided cannulation \>10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5

You may not qualify if:

  • ampullary tumors
  • Billroth II or Roux-en-Y anatomy
  • prior endoscopic sphincterotomy(EST) or biliary stent
  • choledochoduodenal fistulae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Central Study Contacts

zhaoshen Li, MD

CONTACT

86-21-81873241zhaoshenlismmu@gmail.com

feng Liu, MD

CONTACT

86-21-81873262drliuffeng@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 10, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

CN(1)