Clinical trial NCT06092905: Endoscopic Common Bile Duct Stones Clearance During Pregnancy
Official title: Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Common Bile Duct Calculi
Keywords: Common Bile Duct Stones
Endoscopic clearance
Jaundice
Pregnancy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with symptomatic common bile duct stones.

Exclusion Criteria:

* Presence of pancreatitis or cholangitis.

Primary outcomes:
measure: Complications
timeFrame: Till one month after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine, South Valley University Hospitals
Study officials:
affiliation: South Valley University
name: ABDALLAH M ALY, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.