Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-02 @ 12:57 PM
Study NCT ID:
NCT06779266
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2025-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-12', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed bleeding (DB) rate', 'timeFrame': '28 days', 'description': 'symptomatic bleeding occurring after the ESD procedure and within 28 days following the treatment. The symptoms included hematemesis, melena, and decrease in hemoglobin \\>2g/dL.'}], 'secondaryOutcomes': [{'measure': 'Overall Procedure Time (OPT)', 'timeFrame': 'procedural', 'description': 'Measured in minutes and based on the procedural protocol.'}, {'measure': 'Perforation Rate', 'timeFrame': '28 days', 'description': 'Defined as post-procedural clinical signs of peritonitis with radiological signs of air in the peritoneal cavity.'}, {'measure': 'Length of Hospital Stay (HS)', 'timeFrame': '28 days', 'description': 'The time from the procedure to the discharge measured in days and based on the hospital database.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Hand Suturing', 'Suturing Techniques', 'Endoscopic Submucosal Dissection', 'Gastrointestinal Bleeding', 'Endoscopic Closure Techniques'], 'conditions': ['Endoscopic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '35648969', 'type': 'BACKGROUND', 'citation': 'Jiang W, Cen L, Dong C, Zhu S, Shen Z, Li D. Prophylactic Clipping to Prevent Delayed Bleeding and Perforation After Endoscopic Submucosal Dissection and Endoscopic Mucosal Resection: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2022 Sep 1;56(8):643-653. doi: 10.1097/MCG.0000000000001721. Epub 2022 May 25.'}, {'pmid': '39193787', 'type': 'BACKGROUND', 'citation': 'Goto O, Morita Y, Takayama H, Hirasawa K, Sato C, Oyama T, Takahashi A, Abe S, Saito Y, Ono H, Kawata N, Otsuka T, Iwakiri K. Endoscopic hand suturing has the potential to reduce bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic agents: Multicenter phase II study. Dig Endosc. 2025 Mar;37(3):266-274. doi: 10.1111/den.14911. Epub 2024 Aug 28.'}, {'pmid': '36000962', 'type': 'BACKGROUND', 'citation': 'Jia Y, Zhai G, Wang E, Li P. Efficacy of local hemostatic agents after endoscopic submucosal dissection: a meta-analysis. Minim Invasive Ther Allied Technol. 2022 Oct;31(7):1017-1025. doi: 10.1080/13645706.2022.2111217. Epub 2022 Aug 24.'}, {'pmid': '36882090', 'type': 'BACKGROUND', 'citation': 'Libanio D, Pimentel-Nunes P, Bastiaansen B, Bisschops R, Bourke MJ, Deprez PH, Esposito G, Lemmers A, Leclercq P, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, Fuccio L, Bhandari P, Dinis-Ribeiro M. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2023 Apr;55(4):361-389. doi: 10.1055/a-2031-0874. Epub 2023 Mar 7.'}, {'pmid': '20189503', 'type': 'BACKGROUND', 'citation': 'Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding.', 'detailedDescription': 'Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding. The retrospective single-center study included individuals who underwent endoscopic submucosal dissection in the stomach. The resection site was either left open, clipped, or sutured. The study evaluated the overall procedure time (OPT), bleeding rate (BR), perforation rate, and length of hospital stay (HS). The assessment was conducted to compare the outcomes of "non-sutured vs. sutured" "no closure vs. closure" and "clipped vs. sutured" along with the propensity score matching analysis for reducing a potential selection bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The retrospective study included all individuals who underwent gastric ESD from June 2015 to June 2024 in a single high-volume center and had an Eastern Cooperative Oncology Group performance status score of 0 or 1. All included procedures were performed in a conventional manner. The resection site was either left open, clipped, or sutured.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent gastric ESD from June 2015 to June 2024\n* Eastern Cooperative Oncology Group performance status score of 0 or 1\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06779266', 'briefTitle': 'Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.', 'orgStudyIdInfo': {'id': '2025-0101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No closure', 'description': 'Participants who underwent endoscopic submucosal dissection without additional closure of the resection site.', 'interventionNames': ['Procedure: No closure']}, {'label': 'Sutured', 'description': 'Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope suturing.', 'interventionNames': ['Procedure: Suturing']}, {'label': 'Clipped', 'description': 'Participants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope clips.', 'interventionNames': ['Procedure: Clipping']}], 'interventions': [{'name': 'Suturing', 'type': 'PROCEDURE', 'otherNames': ['Endoscopic Hand Suturing', 'Endoscopic Through-the-scope Suturing'], 'description': 'Endoscopic Suturing is a technique of the wound closure after advanced endoscopic third-space resections in the upper and lower gastrointestinal tract. In this technique, the needle is held on the opposite side from the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated from the middle of the wound to create a symmetrical structure.', 'armGroupLabels': ['Sutured']}, {'name': 'Clipping', 'type': 'PROCEDURE', 'otherNames': ['Endoscopic Through-the-scope Suturing'], 'description': 'Clipping is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the through-the-scope clips are delivered to the site through the working canal. The arms of the clip are properly put on the both sides of the defect and the clip is closed to seal the margins. The procedure may be repeated along the resection site for complete closure.', 'armGroupLabels': ['Clipped']}, {'name': 'No closure', 'type': 'PROCEDURE', 'description': 'The resection site after endoscopic submucosal dissection was left open, without additional closure.', 'armGroupLabels': ['No closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Michal Spychalski, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Lodz'}, {'name': 'Zofia Orzeszko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University in Cracow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We intend to share the encrypted data with other investigators after appropriate application and approval of the study chair.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zofia Orzeszko', 'investigatorAffiliation': 'Jagiellonian University'}}}}