Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:28 AM
Study NCT ID:
NCT07410767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Endoscopic Resections for Rectal Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major intraprocedural bleeding rate', 'timeFrame': 'During the procedure', 'description': 'Bleeding occurring during the procedure that required advanced endoscopic hemostatic interventions beyond standard coagulation with the tip of the knife of coagulation forceps, resulted in hemodynamic instability, caused a significant prolongation of the procedure over 15 minutes (based on video), or led to procedure interruption or conversion'}, {'measure': 'Intraprocedural perforation rate', 'timeFrame': 'During the procedure', 'description': 'Full-thickness defect of the gastrointestinal wall identified during the procedure, evidenced by direct visualization of extraluminal structures (mesorectum or peritoneal cavity), or confirmed by the presence of free air on imaging performed immediately after the procedure.'}, {'measure': 'Delayed bleeding rate', 'timeFrame': 'Within 28 days after the procedure', 'description': 'Symptomatic bleeding including hematemesis, melena, or a hemoglobin decrease of more than 2 g/dL.'}, {'measure': 'Delayed perforation rate', 'timeFrame': 'Within 14 days after the procedure', 'description': 'Clinical signs of peritonitis accompanied by radiological evidence of free intraperitoneal air.'}, {'measure': 'Post-coagulation syndrome rate', 'timeFrame': 'Within 28 days following the procedure', 'description': 'The occurrence of localized abdominal pain or peritoneal irritation signs after EID, accompanied by inflammatory response (elevated white blood cell count or C-reactive protein), in the absence of radiological or endoscopic evidence of perforation.'}, {'measure': 'The need for emergency interventions', 'timeFrame': 'Within 30 days after the procedure', 'description': 'Any unplanned therapeutic intervention related to the index procedure during hospitalization or follow-up, including repeat endoscopy, endoscopic or radiological intervention, blood transfusion, or surgical treatment. Planned surveillance procedures were not considered additional interventions.'}, {'measure': 'Procedure-related mortality rate', 'timeFrame': 'Within 30 days after the procedure', 'description': 'Number of deaths occurring within 30 days of the index procedure that was directly attributable to the procedure or to procedure-related complications. Deaths unrelated to the procedure were reported but not considered procedure-related mortality.'}], 'secondaryOutcomes': [{'measure': 'En bloc resection rate', 'timeFrame': 'Intraprocedural', 'description': 'The rate of lesions removed in a single specimen, enabling accurate macroscopic and histological assessment as reported by an endoscopist in a procedure protocol.'}, {'measure': 'Complete resection rate', 'timeFrame': 'Within 30 days after the procedure', 'description': 'The rate of lesions resected completely according to the pathological examination of the resected specimen.'}, {'measure': 'Procedure time', 'timeFrame': 'Intraprocedural', 'description': 'Procedure time was evaluated on the procedure video and defined as the interval from the insertion of the scope to its final withdrawal measured in minutes; anesthesia-related time was not included.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Within 30 days after the procedure', 'description': 'The number of days from the day of the procedure (day 0) to the day of hospital discharge.'}, {'measure': 'The need for additional treatment', 'timeFrame': 'Within 12 months after the procedure', 'description': 'The number of patients who required completion surgery or adjuvant (chemo)radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Rectal Adenocarcinoma', 'Rectal Adenoma', 'Rectal Neuroendocrine Neoplasm', 'Recurrent Rectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer.\n\nRectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established.\n\nThis multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches.\n\nThe results of this study may help guide treatment selection and improve care for people with rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rectal neoplasms treated with advanced endoscopic resection in a tertiary center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with rectal neoplasms treated by advanced endoscopic resection\n\nExclusion Criteria:\n\n* hybrid resection performed\n* full-thickness resection performed\n* essential procedural or outcome data were unavailable'}, 'identificationModule': {'nctId': 'NCT07410767', 'briefTitle': 'Advanced Endoscopic Resections for Rectal Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Adoption of Advanced Endoscopic Resection Methods in the Treatment of Rectal Neoplasms', 'orgStudyIdInfo': {'id': '1072.6120.2.63.2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESD', 'description': 'Patients who underwent endoscopic submucosal dissection for rectal neoplasm', 'interventionNames': ['Procedure: Endoscopic submucosal dissection']}, {'label': 'EID', 'description': 'Patients who underwent endoscopic intermuscular dissection for rectal neoplasm', 'interventionNames': ['Procedure: Endoscopic intramuscular dissection']}], 'interventions': [{'name': 'Endoscopic submucosal dissection', 'type': 'PROCEDURE', 'description': 'Endoscopic submucosal dissection is an advanced endoscopic technique used to remove rectal tumors in one piece through the endoscope. A circumferential incision is then made in the mucosa, followed by careful dissection within the submucosal layer until the lesion is completely removed. This technique enables precise pathological assessment of tumor margins and depth of invasion and is typically used for lesions suspected to have superficial submucosal invasion without clear evidence of lymph node involvement. The procedure is performed using standard therapeutic endoscopic equipment and electrosurgical devices.', 'armGroupLabels': ['ESD']}, {'name': 'Endoscopic intramuscular dissection', 'type': 'PROCEDURE', 'description': 'Endoscopic intermuscular dissection is an advanced endoscopic resection technique designed for rectal tumors with suspected deeper submucosal invasion. Following mucosal incision, the dissection is intentionally performed in the plane between the inner circular and outer longitudinal muscle layers of the rectal wall. This allows deeper en bloc tumor removal compared with conventional endoscopic submucosal dissection. The goal of this technique is to achieve complete resection while potentially avoiding radical surgery in selected patients. The procedure is performed endoscopically using specialized dissection knives and electrosurgical systems and requires advanced operator expertise.', 'armGroupLabels': ['EID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Krakow', 'country': 'Poland', 'contacts': [{'name': 'Zofia Orzeszko, MD', 'role': 'CONTACT', 'email': 'zofia.orzeszko@uj.edu.pl', 'phone': '+123797145'}], 'facility': 'Jagiellonian University in Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Zofia Orzeszko, MD', 'role': 'CONTACT', 'email': 'zofia.orzeszko@uj.edu.pl', 'phone': '+123797145'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Permission for data sharing was not included in the bioethics committee approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Consultant General Surgeon', 'investigatorFullName': 'Zofia Orzeszko', 'investigatorAffiliation': 'Jagiellonian University'}}}}