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Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Primary Purpose

Common Bile Duct Calculi

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Calculi

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All cases of difficult common bile duct stones leading to variable occlusion. Patients fit for intervention. Patients informed consent for study. Exclusion Criteria: Surgically unfit cases according to ASA Locally advanced irresectable cases. Patients refuse consent to participate in the study.

Sites / Locations

  • Assiut universty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

One session application of (ERCP) in the management of common bile duct stones.

Two sessions application of (ERCP) in the management of common bile duct stones.

Arm Description

One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Outcomes

Primary Outcome Measures

Time of procedure.
This is measured in hours.
Rate of stone size reduction.
This is measured in millimeters.
Width of CBD.
This is measured in millimeters.
Degree of stone clearance and complications.
Those are determined by close monitoring of patients whether after ERCP or surgery.
Postoperative morbidity and mortality.
Those are measures in percentage of patients in the study.

Secondary Outcome Measures

Blood loss during the procedure.
This is measured in milliliters.
Postoperative wound infection.
This is measured in percentage of patients in the study.
Postoperative hospital stay.
This is measured in days.
Postoperative hemorrhage.
This is measured in milliliters.
Postoperative 30 day mortality rate.
This is measured in percentage of patients in the study.

Full Information

First Posted
November 1, 2021
Last Updated
July 18, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05746832
Brief Title
Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference
Official Title
Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Detailed Description
Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One session application of (ERCP) in the management of common bile duct stones.
Arm Type
Active Comparator
Arm Description
One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Arm Title
Two sessions application of (ERCP) in the management of common bile duct stones.
Arm Type
Active Comparator
Arm Description
Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
Intervention Description
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Primary Outcome Measure Information:
Title
Time of procedure.
Description
This is measured in hours.
Time Frame
On the day of determined procedure.
Title
Rate of stone size reduction.
Description
This is measured in millimeters.
Time Frame
Baseline.
Title
Width of CBD.
Description
This is measured in millimeters.
Time Frame
Baseline.
Title
Degree of stone clearance and complications.
Description
Those are determined by close monitoring of patients whether after ERCP or surgery.
Time Frame
Baseline.
Title
Postoperative morbidity and mortality.
Description
Those are measures in percentage of patients in the study.
Time Frame
Baseline.
Secondary Outcome Measure Information:
Title
Blood loss during the procedure.
Description
This is measured in milliliters.
Time Frame
Baseline.
Title
Postoperative wound infection.
Description
This is measured in percentage of patients in the study.
Time Frame
Baseline.
Title
Postoperative hospital stay.
Description
This is measured in days.
Time Frame
Baseline.
Title
Postoperative hemorrhage.
Description
This is measured in milliliters.
Time Frame
Baseline.
Title
Postoperative 30 day mortality rate.
Description
This is measured in percentage of patients in the study.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All cases of difficult common bile duct stones leading to variable occlusion. Patients fit for intervention. Patients informed consent for study. Exclusion Criteria: Surgically unfit cases according to ASA Locally advanced irresectable cases. Patients refuse consent to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zyad Osama Harith, resident
Phone
01149863511
Email
zyadosama200000@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Mahmoud Mohammed Sayed, ass prof
Phone
+201271207839
Email
mostafa.sayed@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham Ali Ryad, Prof.
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut universty Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

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Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

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