Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-27 @ 5:32 AM
Study NCT ID:
NCT05965466
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2023-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Incidence of Gallstones After Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], '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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005763', 'term': 'Gastroenterostomy'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Distal gastrectomy and Total gastrectomy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 531}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-16', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of gallstone patients', 'timeFrame': '5years', 'description': 'Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with postoperative complications', 'timeFrame': '5years', 'description': 'The number of patients with postoperative complications such as abdominal haemorrhage, fistula, nausea, vomiting, abdominal infection and incision infection in 2 groups of gastric cancer patients'}, {'measure': 'Number of patients with bile duct stones', 'timeFrame': '5years', 'description': "Two groups of patients with gastric cancer had a follow-up for more than one year. Clinical signs such as Charcot's triad and ultrasound, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) show the number of patients with bile duct stones"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gallstone', 'Gastric Cancer', 'Gastrectomy'], 'conditions': ['Gallstone', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '27433395', 'type': 'RESULT', 'citation': 'Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.'}, {'pmid': '33205309', 'type': 'RESULT', 'citation': 'Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.'}, {'pmid': '38320088', 'type': 'DERIVED', 'citation': 'Zhang B, Nie P, Lin Y, Ma Z, Ma G, Wang Y, Ma Y, Zhao J, Zhang J, Yue P, Jiang N, Zhang X, Tian L, Lu L, Yuan J, Meng W. High incidence of gallstones after Roux-en-Y reconstruction gastrectomy in gastric cancer: a multicenter, long-term cohort study. Int J Surg. 2024 Apr 1;110(4):2253-2262. doi: 10.1097/JS9.0000000000001136.'}]}, 'descriptionModule': {'briefSummary': 'To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.', 'detailedDescription': 'A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Gastric Cancer underwent Gastrectomy\n\nExclusion Criteria:\n\n* Age less than 18 years or age greater than 75 years;\n* Not Roux-en-Y reconstruction;\n* R0 excision is not achieved;\n* Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;\n* Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;\n* Preoperative neoadjuvant chemotherapy or radiotherapy;\n* Previous history of malignant tumours;\n* Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;\n* Gastric perforation or bleeding leading to emergency surgery;\n* Palliative surgical treatment;\n* Incomplete case information.'}, 'identificationModule': {'nctId': 'NCT05965466', 'briefTitle': 'The Incidence of Gallstones After Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study', 'orgStudyIdInfo': {'id': 'GGBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Distal gastrectomy', 'description': 'Distal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.', 'interventionNames': ['Procedure: Distal gastrectomy and radical resection']}, {'type': 'SHAM_COMPARATOR', 'label': 'Total gastrectomy', 'description': 'Total gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.', 'interventionNames': ['Procedure: Total gastrectomy and radical resection']}], 'interventions': [{'name': 'Distal gastrectomy and radical resection', 'type': 'PROCEDURE', 'description': 'Distal gastrectomy and Roux-en-Y anastomosis', 'armGroupLabels': ['Distal gastrectomy']}, {'name': 'Total gastrectomy and radical resection', 'type': 'PROCEDURE', 'description': 'Total gastrectomy and Roux-en-Y anastomosis', 'armGroupLabels': ['Total gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '733099', 'city': 'Wuwei', 'state': 'Gansu', 'country': 'China', 'facility': 'Wuwei Tumor Hospital', 'geoPoint': {'lat': 37.92672, 'lon': 102.63202}}], 'overallOfficials': [{'name': 'Wenbo Meng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}