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RecruitingNCT06092905Updated Oct 23, 2023

Endoscopic Common Bile Duct Stones Clearance During Pregnancy

An observational study in Common Bile Duct Calculi, sponsored by South Valley University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by South Valley University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Common Bile Duct Calculi

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Keywords

  • Common Bile Duct Stones
  • Endoscopic clearance
  • Jaundice
  • Pregnancy
03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 70 observational studies indexed under Gallstones.

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Lead sponsor

South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women with symptomatic common bile duct stones.

Exclusion criteria

Exclusion Criteria:

  • Presence of pancreatitis or cholangitis.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherEndoscopic 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.

06

What researchers measure

Primary outcomes

  1. Complications

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

    Time frame: Till one month after delivery.

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 29164335 ↗
  • 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. PubMed 25983209 ↗
  • 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. PubMed 8293907 ↗
  • 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. PubMed 12591046 ↗
  • 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. PubMed 25952311 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092905
Responsible party
Abdallah Mohamed Taha Aly (Assistant Professor, South Valley University) — Principal investigator
First posted
Oct 23, 2023
Start date
Apr 1, 2023
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Oct 23, 2023

Study contacts

ABDALLAH M ALY, MD
Contact
abdallahsurgery@med.svu.edu.eg
+201011716497
ABDALLAH M ALY, MD
principal investigator · South Valley University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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