Back to resultsEffect of EPBD in ERCP on the Prognosis of Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula (EPBD)
Primary Purpose
Periampullary Diverticula
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EPBD
EST
Sponsored by
About this trial
This is an interventional treatment trial for Periampullary Diverticula focused on measuring EPBD
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.
Sites / Locations
- Renmin Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EPBD
EST
Arm Description
Small incision of the duodenal nipple + EPBD
Large incision of the duodenal nipple
Outcomes
Primary Outcome Measures
Incidence of complications
total complications occurded after operation
time of operation
duration of the ERCP
postoperative recurrent rate
Recurrence rate of choledocholithiasis
Secondary Outcome Measures
Full Information
NCT ID
NCT04254887
First Posted
January 30, 2020
Last Updated
February 2, 2020
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04254887
Brief Title
Effect of EPBD in ERCP on the Prognosis of Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula
Acronym
EPBD
Official Title
EPBD+Small EST VS. Large EST in Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Diverticula
Keywords
EPBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EPBD
Arm Type
Experimental
Arm Description
Small incision of the duodenal nipple + EPBD
Arm Title
EST
Arm Type
Active Comparator
Arm Description
Large incision of the duodenal nipple
Intervention Type
Procedure
Intervention Name(s)
EPBD
Intervention Description
Small incision of the duodenal nipple + EPBD
Intervention Type
Procedure
Intervention Name(s)
EST
Intervention Description
Large incision of the duodenal nipple + EPBD
Primary Outcome Measure Information:
Title
Incidence of complications
Description
total complications occurded after operation
Time Frame
1 month
Title
time of operation
Description
duration of the ERCP
Time Frame
1-4 hours
Title
postoperative recurrent rate
Description
Recurrence rate of choledocholithiasis
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiong Gong, Doctor
Phone
+8618086496360
Email
gongq2019@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Z'hong'chao Zhu, Doctor
Phone
+8613995617151
Email
zhuzhongchao@163.com
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiong Gong, Doctor
Phone
+86 18086496360
Email
gongq201919@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of EPBD in ERCP on the Prognosis of Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula
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