Endoscopic Common Bile Duct Stones Clearance During Pregnancy

Common Bile Duct Calculi Clinical Trial

Official title:

Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092905
• Other study ID #: SVU-MED-SUR11-4-23-3-601
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: South Valley University
• Contact: ABDALLAH M ALY, MD
• Phone: +201011716497
• Email: abdallahsurgery[@]med.svu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women with symptomatic common bile duct stones.

Exclusion Criteria:

• Presence of pancreatitis or cholangitis.

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Calculi
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
Egypt	Qena Faculty of Medicine, South Valley University Hospitals	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor.	Till one month after delivery.