Endoscopic Common Bile Duct Stones Clearance During Pregnancy

Sponsor
South Valley University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06092905
Collaborator
(none)
30
1
8
3.7

Study Details

Study Description

Brief Summary

Background: Pregnancy is associated with a higher risk of common bile duct stones. Currently Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for symptomatic choledocholithiasis. However, ERCP during pregnancy is associated with hazards of radiation exposure, as well as challenging patient positioning and anesthesia

Condition or Disease Intervention/Treatment Phase
  • Other: Endoscopic clearance of common bile duct stones

Detailed Description

This is a retrospective analysis of endoscopic common bile duct stone clearance in pregnant patients with symptomatic choledocholithiasis between June 2015 and June 2023.

Sedation and anesthesia was done by safe medications by senior anesthetist, and the endoscopic procedure was performed in left lateral decubitus instead of prone position. The gravid uterus was kept away from the monopolar electrocautery current pathway. Radiocontrast injection and fluoroscopy was deleted and replaced by trans-abdominal US and endoscopic bile aspiration Data including perioperative outcomes and follow up data will collected, tabulated and analyzed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pregnant women with symptomatic common bile duct stones

Pregnant women with symptomatic common bile duct stones

Other: Endoscopic clearance of common bile duct stones
Under general anesthesia, in left lateral decubitus, endoscopic clearance of common bile duct stones was done. Ultrasonography was used to ensure right positioning of the guide wire in the common bile duct, and ensure stone clearance.

Outcome Measures

Primary Outcome Measures

  1. Complications [Till one month after delivery.]

    any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • Pregnant women with symptomatic common bile duct stones.
Exclusion Criteria:
  • Presence of pancreatitis or cholangitis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qena Faculty of Medicine, South Valley University Hospitals Qinā Egypt

Sponsors and Collaborators

  • South Valley University

Investigators

  • Principal Investigator: ABDALLAH M ALY, MD, South Valley University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdallah Mohamed Taha Aly, Assistant Professor, South Valley University
ClinicalTrials.gov Identifier:
NCT06092905
Other Study ID Numbers:
  • SVU-MED-SUR11-4-23-3-601
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdallah Mohamed Taha Aly, Assistant Professor, South Valley University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023