NCT04254887

Brief Summary

The investigators hypothesized that nipple balloon dilatation could make ERCP more successful and reduce postoperative complications and mortality. So the investigators design this experiment on this assumption.

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
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

February 5, 2020

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

January 30, 2020

Last Update Submit

February 2, 2020

Conditions

Periampullary Diverticula

Keywords

EPBD

Outcome Measures

Primary Outcomes (3)

  • Incidence of complications

    total complications occurded after operation

    1 month

  • time of operation

    duration of the ERCP

    1-4 hours

  • postoperative recurrent rate

    Recurrence rate of choledocholithiasis

    1 year

Study Arms (2)

EPBD

EXPERIMENTAL

Small incision of the duodenal nipple + EPBD

Procedure: EPBD

EST

ACTIVE COMPARATOR

Large incision of the duodenal nipple

Procedure: EST

Interventions

EPBDPROCEDURE

Small incision of the duodenal nipple + EPBD

EPBD
ESTPROCEDURE

Large incision of the duodenal nipple + EPBD

EST

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with choledocholithiasis. 2. During ERCP, the patient was diagnosed as choledocholithiasis combined with duodenal papillary diverticulum. 3. Ages 16 to 75. 4. choledocholithiasis no larger than 1.5 cm

You may not qualify if:

  • Patients with duodenal papillary tumor. 2. Pregnant. 3. Patients with gastrointestinal duct obstruction endoscopy who cannot be operated and who have endoscopic contraindications. 4. Patients with duodenoscopy contraindications. 5. Patients with severe pancreatitis and other serious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Central Study Contacts

Qiong Gong, Doctor

CONTACT

+8618086496360gongq2019@163.com

Z'hong'chao Zhu, Doctor

CONTACT

+8613995617151zhuzhongchao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

October 15, 2019

Primary Completion

June 15, 2020

Study Completion

August 15, 2020

Last Updated

February 5, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)