NCT02958618

Brief Summary

Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in treating common bile duct stones. It had the similar success rate of stone extraction, but its incidence of complications remained uncertain. However, there is no clinical evidence and guideline to define the optimal duration of balloon dilation so far. So we designed a prospective randomized trial to compare the effect of three different duration of balloon dilation during ESBD so that we can find the optimal duration of the balloon dilation.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 5, 2016

Last Update Submit

November 5, 2016

Conditions

Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

  • Post-ERCP pancreatitis

    Patients with abdominal pain and serum amylase levels more than 3 times the upper limit of normal value. CT scanning is the best diagnostic discriminator

    Within 7 days after ESBD

Secondary Outcomes (8)

  • Bleeding

    Within 7 days after ESBD

  • Perforation

    Within 7 days after ESBD

  • Acute cholangitis

    Within 7 days after ESBD

  • Pain

    Within 7 days after ERCP

  • Success rate for clearance of stones

    Within 72 hours after ERCP

  • +3 more secondary outcomes

Study Arms (3)

Duration for 30" group

EXPERIMENTAL

A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 30 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Procedure: 30" group

Duration for 60" group

EXPERIMENTAL

A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 60 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Procedure: 60" group

Duration for 180" group

EXPERIMENTAL

A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 180 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Procedure: 180" group

Interventions

30" groupPROCEDURE

A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 30 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Duration for 30" group
60" groupPROCEDURE

A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 60 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Duration for 60" group
180" groupPROCEDURE

A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18 ) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 180 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.

Duration for 180" group

Eligibility Criteria

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

You may qualify if:

  • CBD stone patients, age≥18 years
  • Stone diameter≤1.5cm

You may not qualify if:

  • Unwilling to consent for the study
  • Previous EST or EPBD
  • Prior surgery of Bismuth Ⅱ and Roux-en-Y
  • Benign or malignant CBD stricture
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Central Study Contacts

Li Kewei, M.D., Ph.D.

CONTACT

+8613003232119keweipig@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

CN(1)