NCT06092905

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 15, 2023

Last Update Submit

October 15, 2023

Conditions

Common Bile Duct Calculi

Keywords

Common Bile Duct StonesEndoscopic clearanceJaundicePregnancy

Outcome Measures

Primary Outcomes (1)

  • Complications

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

    Till one month after delivery.

Study Arms (1)

Pregnant women with symptomatic common bile duct stones

Pregnant women with symptomatic common bile duct stones

Other: Endoscopic clearance of common bile duct stones

Interventions

Endoscopic clearance of common bile duct stonesOTHER

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.

Pregnant women with symptomatic common bile duct stones

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant woman with symptomatic common bile duct stones
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women, presented with symptomatic common bile duct stones to the general surgery department at Qena University Hospital, South Valley University, Egypt, between June 2015 and June 2023. Endoscopy was performed for clearance of the stones.

You may qualify if:

  • Pregnant women with symptomatic common bile duct stones.

You may not qualify if:

  • Presence of pancreatitis or cholangitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

RECRUITING

Related Publications (5)

  • Luo L, Zen H, Xu H, Zhu Y, Liu P, Xia L, He W, Lv N. Clinical characteristics of acute pancreatitis in pregnancy: experience based on 121 cases. Arch Gynecol Obstet. 2018 Feb;297(2):333-339. doi: 10.1007/s00404-017-4558-7. Epub 2017 Nov 21.

    PMID: 29164335BACKGROUND

  • Xu Q, Wang S, Zhang Z. A 23-year, single-center, retrospective analysis of 36 cases of acute pancreatitis in pregnancy. Int J Gynaecol Obstet. 2015 Aug;130(2):123-6. doi: 10.1016/j.ijgo.2015.02.034. Epub 2015 May 2.

    PMID: 25983209BACKGROUND

  • Goldschmiedt M, Wolf L, Shires T. Treatment of symptomatic choledocholithiasis during pregnancy. Gastrointest Endosc. 1993 Nov-Dec;39(6):812-4. doi: 10.1016/s0016-5107(93)70272-2. No abstract available.

    PMID: 8293907BACKGROUND

  • Tham TC, Vandervoort J, Wong RC, Montes H, Roston AD, Slivka A, Ferrari AP, Lichtenstein DR, Van Dam J, Nawfel RD, Soetikno R, Carr-Locke DL. Safety of ERCP during pregnancy. Am J Gastroenterol. 2003 Feb;98(2):308-11. doi: 10.1111/j.1572-0241.2003.07261.x.

    PMID: 12591046BACKGROUND

  • Inamdar S, Berzin TM, Sejpal DV, Pleskow DK, Chuttani R, Sawhney MS, Trindade AJ. Pregnancy is a Risk Factor for Pancreatitis After Endoscopic Retrograde Cholangiopancreatography in a National Cohort Study. Clin Gastroenterol Hepatol. 2016 Jan;14(1):107-14. doi: 10.1016/j.cgh.2015.04.175. Epub 2015 May 5.

    PMID: 25952311BACKGROUND

MeSH Terms

Conditions

GallstonesJaundice

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHyperbilirubinemiaPathologic ProcessesSkin ManifestationsSigns and Symptoms

Study Officials

  • ABDALLAH M ALY, MD

    South Valley University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ABDALLAH M ALY, MD

CONTACT

+201011716497abdallahsurgery@med.svu.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 23, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)