Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT06396806
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2024-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012811', 'term': 'Sigmoid Neoplasms'}], 'ancestors': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012810', 'term': 'Sigmoid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1072}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival rate', 'timeFrame': '3 years after the surgery', 'description': 'odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Total number of retrieved lymph nodes', 'timeFrame': '14 days after the surgery', 'description': 'Compare total number of retrieved lymph nodes in both group'}, {'measure': 'Number of Metastasis Lymph Nodes', 'timeFrame': '14 days after the surgery', 'description': 'Compare number of positive lymph nodes in both group.'}, {'measure': 'The number of lymph nodes at each station', 'timeFrame': '14 days after the surgery'}, {'measure': 'The rate of fluorescence', 'timeFrame': '14 days after the surgery', 'description': 'The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group'}, {'measure': 'Positive rate', 'timeFrame': '14 days after the surgery', 'description': 'The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group'}, {'measure': 'False positive rate', 'timeFrame': '14 days after the surgery', 'description': 'The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group'}, {'measure': 'Negative rate', 'timeFrame': '14 days after the surgery', 'description': 'The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group'}, {'measure': 'False negative rate', 'timeFrame': '14 days after the surgery', 'description': 'The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group'}, {'measure': 'Morbidity rate', 'timeFrame': '30 days after the surgery', 'description': 'This is for the early postoperative complication'}, {'measure': 'mortality rate', 'timeFrame': '30 days after the surgery', 'description': 'mortality, which defined as the event observed within 30 days after surgery'}, {'measure': 'Pathological outcomes checklist', 'timeFrame': '14 days after the surgery', 'description': 'Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin'}, {'measure': '3-year Overall survival rate', 'timeFrame': '3 years after the surgery', 'description': 'Overall survival was defined as the time from surgery to death from any cause'}, {'measure': '5-year Overall survival rate', 'timeFrame': '5 years after the surgery', 'description': 'Overall survival was defined as the time from surgery to death from any cause'}, {'measure': '5-year Disease-free survival rate', 'timeFrame': '5 years after the surgery'}, {'measure': 'Local recurrence rate', 'timeFrame': '3 years after the surgery', 'description': 'Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis.'}, {'measure': 'Postoperative function (voiding function, sexual function) and quality of life', 'timeFrame': '3 years after the surgery'}, {'measure': 'The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate', 'timeFrame': '3 years after the surgery'}, {'measure': 'Minimal Residual Disease, MRD', 'timeFrame': '3 years after the surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sigmoid Cancer']}, 'descriptionModule': {'briefSummary': 'he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 75 years old\n2. Confirmed sigmoid adenocarcinoma cancer pathologically\n3. Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.\n4. CT showed sigmoid colon cancer: T3-4a N+ M0\n5. Patients with non-local recurrence or distant metastasis;\n6. no multiple colorectal cancer;\n7. no neoadjuvant therapy;\n8. physical conditions such as heart, lung, liver and kidney function can tolerate surgery.\n9. Willing and able to provide written informed consent for participation in this study\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors or previous history of malignant tumors;\n2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;\n3. patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;\n4. patients with poor anal function and incontinence before operation;\n5. patients with inflammatory bowel disease or familial adenomatous polyposis\n6. ASA grade ≥ IV and / or ECOG physical status score \\> 2;\n7. patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;\n8. history of severe mental illness;\n9. pregnant or lactating women;\n10. patients with uncontrolled infection before operation;\n11. patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.'}, 'identificationModule': {'nctId': 'NCT06396806', 'briefTitle': 'A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer', 'orgStudyIdInfo': {'id': 'GIHSYSU-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'radical sigmoidectomy', 'description': 'radical sigmoidectomy'}, {'type': 'EXPERIMENTAL', 'label': 'radical sigmoidectomy combined with indocyanine green fluorescence imaging', 'description': 'At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.', 'interventionNames': ['Procedure: indocyanine green fluorescence imaging lymphatic tracing']}], 'interventions': [{'name': 'indocyanine green fluorescence imaging lymphatic tracing', 'type': 'PROCEDURE', 'description': 'At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.', 'armGroupLabels': ['radical sigmoidectomy combined with indocyanine green fluorescence imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun yat-sen University, Sixth Affiliated Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician，Assistant to the dean', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}