Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

NCT05746832 | Unknown

• 1 other identifier: CBD stones managment by ERCP
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (5)

• Time of procedure.

  This is measured in hours.

  On the day of determined procedure.

• Rate of stone size reduction.

  This is measured in millimeters.

  Baseline.

• Width of CBD.

  This is measured in millimeters.

  Baseline.

• Degree of stone clearance and complications.

  Those are determined by close monitoring of patients whether after ERCP or surgery.

  Baseline.

• Postoperative morbidity and mortality.

  Those are measures in percentage of patients in the study.

  Baseline.

Secondary Outcomes (5)

• Blood loss during the procedure.

  Baseline.

• Postoperative wound infection.

  Baseline.

• Postoperative hospital stay.

  Baseline.

• Postoperative hemorrhage.

  Baseline.

• Postoperative 30 day mortality rate.

  Baseline.

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

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

ACTIVE COMPARATOR

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.

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Interventions

Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) PROCEDURE

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.

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.

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases of difficult common bile duct stones leading to variable occlusion.
• Patients fit for intervention.
• Patients informed consent for study.

You may not qualify if:

• Surgically unfit cases according to ASA
• Locally advanced irresectable cases.
• Patients refuse consent to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut universty Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hisham Ali Ryad, Prof.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zyad Osama Harith, resident

CONTACT

01149863511; zyadosama200000@gmail.com

Mostafa Mahmoud Mohammed Sayed, ass prof

CONTACT

+201271207839; mostafa.sayed@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zyad Osama Harith Abulatif (General surgery resident)

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: February 28, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

EG (1)