Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:08 AM
Study NCT ID:
NCT06383793
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077044', 'term': 'EXOSC10 protein, human'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 year survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.\n\nThis article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'preoperative confirmation through electronic gastroscopy and enhanced CT that the lesion was situated in the fundus, middle and upper third of the gastric body, or the entire stomach', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:(1) preoperative confirmation through electronic gastroscopy and enhanced CT that the lesion was situated in the fundus, middle and upper third of the gastric body, or the entire stomach; (2) postoperative pathology confirming adenocarcinoma; (3) utilization of either overlap esophagojejunal anastomosis or π-shaped anastomosis in total laparoscopic total gastrectomy.\n\n\\-\n\nExclusion Criteria:(1) patients with severe preoperative cardiac, hepatic, renal, and pulmonary complications; (2) preoperative neoadjuvant chemotherapy; (3) a history of previous abdominal surgery; (4) patients requiring combined resection due to infiltration of other organs during the operation; (5) patients with incomplete pathological or clinical data. All patients signed informed consent.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06383793', 'briefTitle': 'Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy', 'orgStudyIdInfo': {'id': 'Northjiangsu000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'overlap', 'interventionNames': ['Procedure: overlap']}, {'label': 'Π', 'interventionNames': ['Procedure: overlap']}], 'interventions': [{'name': 'overlap', 'type': 'PROCEDURE', 'description': 'Π', 'armGroupLabels': ['overlap', 'Π']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225000', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yifan Cheng', 'role': 'CONTACT', 'email': 'cyfchengyifan528@sina.com', 'phone': '8615267258283'}], 'facility': 'Yifan Cheng', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Daorong Wang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}