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Status unknownNCT04254887EPBDUpdated Feb 5, 2020

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

An interventional study of EPBD and EST in Periampullary Diverticula, sponsored by Renmin Hospital of Wuhan University. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Periampullary Diverticula

Keywords

  • EPBD
03

In context

Choledocholithiasis

104 studies on the registry are indexed under Choledocholithiasis; 23 are open to participants now.

This study's planned enrollment of 128 is above the median of 108 across 70 interventional studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    EPBD

    Small incision of the duodenal nipple + EPBD

    Procedure: EPBD

  • Active comparator
    EST

    Large incision of the duodenal nipple

    Procedure: EST

Interventions

  • ProcedureEPBD

    Small incision of the duodenal nipple + EPBD

  • ProcedureEST

    Large incision of the duodenal nipple + EPBD

06

What researchers measure

Primary outcomes

  1. Incidence of complications

    total complications occurded after operation

    Time frame: 1 month

  2. time of operation

    duration of the ERCP

    Time frame: 1-4 hours

  3. postoperative recurrent rate

    Recurrence rate of choledocholithiasis

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04254887
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Oct 15, 2019
Primary completion
Jun 15, 2020 (estimated)
Completion
Aug 15, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

Qiong Gong, Doctor
Contact
gongq2019@163.com
+8618086496360
Z'hong'chao Zhu, Doctor
Contact
zhuzhongchao@163.com
+8613995617151

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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