Effect of EPBD in ERCP on the Prognosis of Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula

NCT ID: NCT04254887

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-08-15

Brief Summary

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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.

Detailed Description

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The incidence of periampullary diverticula in patients with choledocholithiasis is very high at 47.1%. A large number of literatures refered that duodenal papillary diverticulum is a high risk factor for postoperative complications and recurrence of choledocholithiasis . Till now, there have been no randomized controlled trials to explore the effect of nipple balloon dilatation (EPLBD) on the treatment and prognosis of patients with choledocholithiasis complicated with periampullary diverticula (found during ERCP).

Conditions

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Periampullary Diverticula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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EPBD

Small incision of the duodenal nipple + EPBD

Group Type EXPERIMENTAL

EPBD

Intervention Type PROCEDURE

Small incision of the duodenal nipple + EPBD

EST

Large incision of the duodenal nipple

Group Type ACTIVE_COMPARATOR

EST

Intervention Type PROCEDURE

Large incision of the duodenal nipple + EPBD

Interventions

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EPBD

Small incision of the duodenal nipple + EPBD

Intervention Type PROCEDURE

EST

Large incision of the duodenal nipple + EPBD

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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

Exclusion Criteria

1. 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiong Gong, Doctor

Role: CONTACT

+8618086496360

Z'hong'chao Zhu, Doctor

Role: CONTACT

+8613995617151

Facility Contacts

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Qiong Gong, Doctor

Role: primary

+86 18086496360

Other Identifiers

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ERCP-0002

Identifier Type: -

Identifier Source: org_study_id

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