Endoscopic Common Bile Duct Stones Clearance During Pregnancy

NCT ID: NCT06092905

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Common Bile Duct Calculi

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pregnant women with symptomatic common bile duct stones

Pregnant women with symptomatic common bile duct stones

Endoscopic clearance of common bile duct stones

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with symptomatic common bile duct stones.

Exclusion Criteria

* Presence of pancreatitis or cholangitis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Abdallah Mohamed Taha Aly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ABDALLAH M ALY, MD

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Locations

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Qena Faculty of Medicine, South Valley University Hospitals

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ABDALLAH M ALY, MD

Role: CONTACT

+201011716497

Facility Contacts

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Abdallah M Taha, MD

Role: primary

+201011617497

References

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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.

Reference Type BACKGROUND
PMID: 29164335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25983209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8293907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12591046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25952311 (View on PubMed)

Other Identifiers

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SVU-MED-SUR11-4-23-3-601

Identifier Type: -

Identifier Source: org_study_id

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