Effect of EPBD in ERCP on the Prognosis of Patients With... | NCT04254887

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

NCT04254887

Sponsor

Renmin Hospital of Wuhan University

Status

Unknown status

Last Update Posted

Feb 5, 2020Actual

Enrollment

128Estimated

Phase

Not Applicable

Conditions

Periampullary Diverticula

Interventions

EPBD
EST

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2019Actual

Primary Completion Date

Jun 15, 2020Estimated

Completion Date

Aug 15, 2020Estimated

First Submitted Date

Jan 30, 2020

First Submission Date that Met QC Criteria

Feb 2, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EPBD	Experimental	Small incision of the duodenal nipple + EPBD	Procedure: EPBD
EST	Active Comparator	Large incision of the duodenal nipple	Procedure: EST

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPBD	Procedure	Small incision of the duodenal nipple + EPBD	EPBD
EST

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiong Gong, Doctor	Contact	+8618086496360		gongq2019@163.com
Z'hong'chao Zhu, Doctor	Contact	+8613995617151		zhuzhongchao@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renmin Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430060	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided