Common Bile Duct CalculiNCT06092905
Endoscopic Common Bile Duct Stones Clearance During Pregnancy
An observational study of Common Bile Duct Calculi, run by South Valley University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- Endoscopic clearance of common bile duct stones
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
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.
Who may be able to join
- Pregnant women with symptomatic common bile duct stones.
Who cannot join
- Presence of pancreatitis or cholangitis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Qena Faculty of Medicine, South Valley University Hospitals
Qina
Abdallah M Taha, MD, +201011617497, abdallahsurgery@med.svu.edu.eg
Abdallah M Taha, MD
About this study
Official title: Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions
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.
- Conditions
- Common Bile Duct Calculi
- Being tested
- Endoscopic clearance of common bile duct stones
- Keywords
- Common Bile Duct Stones, Endoscopic clearance, Jaundice, Pregnancy
- Medical subject headings
- Gallstones, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with symptomatic common bile duct stones | Pregnant women with symptomatic common bile duct stones Receives: Other: Endoscopic clearance of common bile duct stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor.
Measured: Till one month after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Apr 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Taha Aly, South Valley University
- Investigators
- ABDALLAH M ALY, MD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092905
- Sponsor's protocol ID
- SVU-MED-SUR11-4-23-3-601
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29164335Xu 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 25983209Goldschmiedt 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 8293907Tham 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 12591046Inamdar 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions
- ClinicalTrials.gov ID
- NCT06092905
- Acronym / sponsor ID
- SVU-MED-SUR11-4-23-3-601
- Conditions
- Common Bile Duct Calculi
- Keywords
- Common Bile Duct Stones, Endoscopic clearance, Jaundice, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with symptomatic common bile duct stones | – | Other: Endoscopic clearance of common bile duct stonesPregnant women with symptomatic common bile duct stones |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant women with symptomatic common bile duct stones.
Key exclusion criteria (1 listed)
- Presence of pancreatitis or cholangitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic clearance of common bile duct stonesUnder 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. | Other | Pregnant women with symptomatic common bile duct stones |
Primary outcome
Complications
Time frame: Till one month after delivery.
any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 29164335Luo 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.
- Background: PubMed 25983209Xu 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.
- Background: PubMed 8293907Goldschmiedt 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.
- Background: PubMed 12591046Tham 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.
- Background: PubMed 25952311Inamdar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABDALLAH M ALY, MD principal investigator
South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Calculi, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ABDALLAH M ALY, MD (+201011716497, abdallahsurgery@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Till one month after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092905, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.