Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:36 PM
Study NCT ID:
NCT07453433
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Submucosal Pressure Ejection Endoscopic Dissection for Early Gastric Cancer: a Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total procedure time', 'timeFrame': 'Immediately after surgery', 'description': 'Average time to complete endoscopic resection'}, {'measure': 'Circumferential incision time', 'timeFrame': 'Immediately after surgery', 'description': 'Average time for APC labeling of the lesion margin during circumferential incision'}, {'measure': 'Dissection time', 'timeFrame': 'Immediately after surgery', 'description': 'Average time to complete endoscopic dissection'}, {'measure': 'Dissection speed', 'timeFrame': 'Immediately after surgery', 'description': 'Average speed of endoscopic dissection'}], 'secondaryOutcomes': [{'measure': 'Completeness of en bloc resection', 'timeFrame': 'Immediately after surgery', 'description': 'Number of patients with complete lesion resection / Total number of subjects'}, {'measure': 'Adverse event rate', 'timeFrame': 'Immediately after surgery and one month post-surgery', 'description': 'The proportion of adverse events occurring in subjects following surgery (though not necessarily causally related to treatment), encompassing perforation complications, myomere injuries, intraoperative blood loss, thermocoagulation forceps replacements, delayed bleeding, and delayed perforation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Resection', 'Early gastric cancer'], 'conditions': ['Endoscopic Resection', 'Early Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Endoscopic submucosal dissection (ESD) is a technically difficult and time-consuming procedure. Several water-jet knives have been developed to address this issue. The aim of this study was to develop a new ESD method using continuous low-pressure water injection at 1-2 atmosphere with a tip-injected electric knife while dissection simultaneous cutting, dissection, electrocoagulation, and hemostasis, which was so called as submucosal pressure ejection endoscopic dissection (SPEED) to treat early gastric cancer and compare the efficacy and safety with conventional methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients who underwent ESD for EGC were enrolled at Shanghai East Hospital between January 2019 and December 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 years;\n2. histologically proven early gastric adenocarcinoma;\n3. meeting the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2021 ;\n4. Eastern Cooperative Oncology Group performance status ≤ 2;\n5. adequate hematological function (hemoglobin ≥ 9 g/dL, platelets ≥ 50 000/mm3#international normalized ratio#1.5);\n6. sufficient renal function (serum creatinine ≤ 2.0 mg/dL); and (7) adequate hepatic function (serum aspartate aminotransferase ≤ 100 IU/ L, serum alanine aminotransferase ≤ 100 IU/L).\n\nExclusion Criteria:\n\n1. pregnancy or breastfeeding;\n2. difficulty obtaining consent due to psychiatric disorder;\n3. multiple lesions;\n4. history of gastrectomy or gastrointestinal reconstruction surgery.'}, 'identificationModule': {'nctId': 'NCT07453433', 'briefTitle': 'Submucosal Pressure Ejection Endoscopic Dissection for Early Gastric Cancer: a Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Submucosal Pressure Ejection Endoscopic Dissection for Early Gastric Cancer: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2025YS-205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Submucosal pressure ejection endoscopic dissection (SPEED)', 'description': 'A new ESD method using continuous low-pressure water injection at 1-2 atmosphere with a tip-injected electric knife while dissection simultaneous cutting, dissection, electrocoagulation, and hemostasis, which was so called as submucosal pressure ejection endoscopic dissection (SPEED).'}, {'label': 'Conventional ESD (C-ESD)', 'description': 'A traditional ESD model. Submucosal injection is performed separately from circumferential cutting, dissection, electrocoagulation, and hemostasis. During the submucosal dissection procedures, submucosal injection is performed with the tip of the knife first, followed by the above operations, rather than simultaneously.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital', 'investigatorFullName': 'Yingjie Ji', 'investigatorAffiliation': 'Shanghai East Hospital'}}}}