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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04254887

Acronym

EPBD

Enrollment

128

Registered

2020-02-05

Start date

2019-10-15

Completion date

2020-08-15

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periampullary Diverticula

Keywords

EPBD

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.

Detailed 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).

Interventions

PROCEDUREEPBD

Small incision of the duodenal nipple + EPBD

PROCEDUREEST

Large incision of the duodenal nipple + EPBD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactQiong Gong, Doctor

gongq2019@163.com+8618086496360

Backup ContactZ'hong'chao Zhu, Doctor

zhuzhongchao@163.com+8613995617151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026