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

Wuhan University

Status: Unknown

Conditions: Periampullary Diverticula

Treatments: Procedure: EPBD; Procedure: EST

Study type: Interventional

Funder types: Other

Identifiers

NCT04254887

ERCP-0002

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 128 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

EPBD

Experimental group

Description:

Small incision of the duodenal nipple + EPBD

Treatment:

Procedure: EPBD

EST

Active Comparator group

Description:

Large incision of the duodenal nipple

Treatment:

Procedure: EST