Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06092905
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Common Bile Duct Stones Clearance During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D007565', 'term': 'Jaundice'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2023-10-15', 'studyFirstSubmitQcDate': '2023-10-15', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Till one month after delivery.', 'description': 'any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Common Bile Duct Stones', 'Endoscopic clearance', 'Jaundice', 'Pregnancy'], 'conditions': ['Common Bile Duct Calculi']}, 'referencesModule': {'references': [{'pmid': '29164335', 'type': 'BACKGROUND', '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.'}, {'pmid': '25983209', 'type': 'BACKGROUND', '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.'}, {'pmid': '8293907', 'type': 'BACKGROUND', '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.'}, {'pmid': '12591046', 'type': 'BACKGROUND', '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.'}, {'pmid': '25952311', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'This is a retrospective analysis of endoscopic common bile duct stone clearance in pregnant patients with symptomatic choledocholithiasis between June 2015 and June 2023.\n\nSedation 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'Pregnant woman with symptomatic common bile duct stones', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with symptomatic common bile duct stones.\n\nExclusion Criteria:\n\n* Presence of pancreatitis or cholangitis.'}, 'identificationModule': {'nctId': 'NCT06092905', 'briefTitle': 'Endoscopic Common Bile Duct Stones Clearance During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions', 'orgStudyIdInfo': {'id': 'SVU-MED-SUR11-4-23-3-601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with symptomatic common bile duct stones', 'description': 'Pregnant women with symptomatic common bile duct stones', 'interventionNames': ['Other: Endoscopic clearance of common bile duct stones']}], 'interventions': [{'name': 'Endoscopic clearance of common bile duct stones', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Pregnant women with symptomatic common bile duct stones']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdallah M Taha, MD', 'role': 'CONTACT', 'email': 'abdallahsurgery@med.svu.edu.eg', 'phone': '+201011617497'}, {'name': 'Abdallah M Taha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qena Faculty of Medicine, South Valley University Hospitals', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'ABDALLAH M ALY, MD', 'role': 'CONTACT', 'email': 'abdallahsurgery@med.svu.edu.eg', 'phone': '+201011716497'}], 'overallOfficials': [{'name': 'ABDALLAH M ALY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abdallah Mohamed Taha Aly', 'investigatorAffiliation': 'South Valley University'}}}}