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

Periampullary Diverticula Clinical Trial

— EPBD  

Official title:

EPBD+Small EST VS. Large EST in Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254887
• Other study ID #: ERCP-0002
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: October 2019
• Source: Renmin Hospital of Wuhan University
• Contact: Qiong Gong, Doctor
• Phone: +8618086496360
• Email: gongq2019[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: August 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choledocholithiasis
• Diverticulum
• Periampullary Diverticula

Intervention

Procedure:
• EPBD
Small incision of the duodenal nipple + EPBD
• EST
Large incision of the duodenal nipple + EPBD

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications	total complications occurded after operation	1 month
Primary	time of operation	duration of the ERCP	1-4 hours
Primary	postoperative recurrent rate	Recurrence rate of choledocholithiasis	1 year