Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 9:52 PM
Study NCT ID:
NCT05029934
Status:
TERMINATED
Last Update Posted:
2023-07-05
First Post:
2021-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will not be informed about the use of EndoClot adhesive'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'use of EndoClot adhesive after resection vs no use of any preventive action against delayed bleeding (control group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'whyStopped': 'insufficient recruitment of study patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-01', 'studyFirstSubmitDate': '2021-08-29', 'studyFirstSubmitQcDate': '2021-08-29', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delayed bleeding complication: hospitalization', 'timeFrame': '30 days', 'description': 'hospitalization after subsequent return to unit / health care facility for evaluation of rectal bleeding'}, {'measure': 'delayed bleeding complication: transfusion', 'timeFrame': '30 days', 'description': 'a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required transfusion'}, {'measure': 'delayed bleeding complication: repeat endoscopy', 'timeFrame': '30 days', 'description': 'a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required a repeat colonoscopy or sigmoidoscopy for examination of the polypectomy site or control of bleeding'}, {'measure': 'delayed bleeding complication:', 'timeFrame': '30 days', 'description': 'a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required surgery'}], 'secondaryOutcomes': [{'measure': 'Technical handling', 'timeFrame': '20 minutes (assumed deployment time)', 'description': 'product deployment assumed quantity of entire vial: \\< 50%/50-70%/100%'}, {'measure': 'Overall complications', 'timeFrame': 'procedure to day 30', 'description': 'an aggregate of all complications that occur at the time of the procedure or during follow-up'}, {'measure': 'Factors associated with complications: polyp size', 'timeFrame': '30 days', 'description': 'Factors that may be associated with complications, esp. bleeding'}, {'measure': 'Factors associated with complications: polyp location', 'timeFrame': '30 days', 'description': 'Factors that may be associated with complications, esp. bleeding: location of the polyp in the colon (right, left, rectum)'}, {'measure': 'Factors associated with complications: polyp histology', 'timeFrame': '30 days', 'description': 'Factors that may be associated with complications, esp. bleeding'}, {'measure': 'Factors associated with complications: polyp morphology', 'timeFrame': '30 days', 'description': 'Factors that may be associated with complications, esp. bleeding'}, {'measure': 'Factors associated with complications: polyp resection time', 'timeFrame': '30 days', 'description': 'Factors that may be associated with complications, esp. bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon endoscopic mucosa resection (EMR)', 'delayed bleeding', 'colonoscopy', 'polyp resection'], 'conditions': ['Wound Endoscopical, Colon', 'After Polyp Resection, Colon']}, 'referencesModule': {'references': [{'pmid': '30885778', 'type': 'BACKGROUND', 'citation': 'Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.'}, {'pmid': '19474385', 'type': 'BACKGROUND', 'citation': 'Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.'}, {'pmid': '11868011', 'type': 'BACKGROUND', 'citation': 'Brooker JC, Saunders BP, Shah SG, Thapar CJ, Suzuki N, Williams CB. Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations. Gastrointest Endosc. 2002 Mar;55(3):371-5. doi: 10.1067/mge.2002.121597.'}, {'pmid': '15278051', 'type': 'BACKGROUND', 'citation': 'Conio M, Repici A, Demarquay JF, Blanchi S, Dumas R, Filiberti R. EMR of large sessile colorectal polyps. Gastrointest Endosc. 2004 Aug;60(2):234-41. doi: 10.1016/s0016-5107(04)01567-6.'}, {'pmid': '20588036', 'type': 'BACKGROUND', 'citation': "Ferrara F, Luigiano C, Ghersi S, Fabbri C, Bassi M, Landi P, Polifemo AM, Billi P, Cennamo V, Consolo P, Alibrandi A, D'Imperio N. Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps. Digestion. 2010;82(4):213-20. doi: 10.1159/000284397. Epub 2010 Jun 24."}, {'pmid': '21392504', 'type': 'BACKGROUND', 'citation': 'Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.'}, {'pmid': '19748615', 'type': 'BACKGROUND', 'citation': 'Swan MP, Bourke MJ, Alexander S, Moss A, Williams SJ. Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos). Gastrointest Endosc. 2009 Dec;70(6):1128-36. doi: 10.1016/j.gie.2009.05.039. Epub 2009 Sep 12.'}, {'pmid': '17558911', 'type': 'BACKGROUND', 'citation': 'Arebi N, Swain D, Suzuki N, Fraser C, Price A, Saunders BP. Endoscopic mucosal resection of 161 cases of large sessile or flat colorectal polyps. Scand J Gastroenterol. 2007 Jul;42(7):859-66. doi: 10.1080/00365520601137280.'}, {'pmid': '17179057', 'type': 'BACKGROUND', 'citation': 'Levin TR, Zhao W, Conell C, Seeff LC, Manninen DL, Shapiro JA, Schulman J. Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med. 2006 Dec 19;145(12):880-6. doi: 10.7326/0003-4819-145-12-200612190-00004.'}, {'pmid': '19850154', 'type': 'BACKGROUND', 'citation': 'Ko CW, Riffle S, Michaels L, Morris C, Holub J, Shapiro JA, Ciol MA, Kimmey MB, Seeff LC, Lieberman D. Serious complications within 30 days of screening and surveillance colonoscopy are uncommon. Clin Gastroenterol Hepatol. 2010 Feb;8(2):166-73. doi: 10.1016/j.cgh.2009.10.007. Epub 2009 Oct 20.'}, {'pmid': '27296945', 'type': 'BACKGROUND', 'citation': 'Reumkens A, Rondagh EJ, Bakker CM, Winkens B, Masclee AA, Sanduleanu S. Post-Colonoscopy Complications: A Systematic Review, Time Trends, and Meta-Analysis of Population-Based Studies. Am J Gastroenterol. 2016 Aug;111(8):1092-101. doi: 10.1038/ajg.2016.234. Epub 2016 Jun 14.'}, {'pmid': '28779355', 'type': 'BACKGROUND', 'citation': 'Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.'}, {'pmid': '25681402', 'type': 'BACKGROUND', 'citation': 'Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.'}, {'pmid': '27708518', 'type': 'BACKGROUND', 'citation': 'Boumitri C, Mir FA, Ashraf I, Matteson-Kome ML, Nguyen DL, Puli SR, Bechtold ML. Prophylactic clipping and post-polypectomy bleeding: a meta-analysis and systematic review. Ann Gastroenterol. 2016 Oct-Dec;29(4):502-508. doi: 10.20524/aog.2016.0075. Epub 2016 Jul 28.'}, {'pmid': '19889407', 'type': 'BACKGROUND', 'citation': 'ASGE Standards of Practice Committee; Anderson MA, Ben-Menachem T, Gan SI, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Lichtenstein DR, Maple JT, Shen B, Strohmeyer L, Baron T, Dominitz JA. Management of antithrombotic agents for endoscopic procedures. Gastrointest Endosc. 2009 Dec;70(6):1060-70. doi: 10.1016/j.gie.2009.09.040. Epub 2009 Nov 3. No abstract available.'}, {'pmid': '2032596', 'type': 'BACKGROUND', 'citation': 'Karita M, Tada M, Okita K, Kodama T. Endoscopic therapy for early colon cancer: the strip biopsy resection technique. Gastrointest Endosc. 1991 Mar-Apr;37(2):128-32. doi: 10.1016/s0016-5107(91)70669-x.'}, {'pmid': '28652912', 'type': 'BACKGROUND', 'citation': 'Tullavardhana T, Akranurakkul P, Ungkitphaiboon W, Songtish D. Efficacy of submucosal epinephrine injection for the prevention of postpolypectomy bleeding: A meta-analysis of randomized controlled studies. Ann Med Surg (Lond). 2017 Jun 6;19:65-73. doi: 10.1016/j.amsu.2017.05.035. eCollection 2017 Jul.'}, {'pmid': '30296436', 'type': 'BACKGROUND', 'citation': 'Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Effective and safe resection of larger polyps is particularly important due to their higher potential of malignancy. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) (and occasionally endoscopic submucosal dissection (ESD)) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-10% of patients. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.\n\nOur primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.', 'detailedDescription': 'Colorectal cancer is the second most common cause of cancer death in the United States and Europe. The effectiveness of colonoscopy in reducing the risk of dying from colorectal cancer relies on the detection and safe resection of neoplastic polyps to prevent incident cancers. Most polyps are small and can be easily removed using snare with or without electrocautery. Because the risk of prevalent cancer or transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important.\n\nEndoscopic mucosal resection (EMR) is evolving as the primary endoscopic technique to remove large non-pedunculated polyps. These flat or sessile polyps are defined as lateral spreading tumors with a low vertical axis that extend laterally along the luminal wall. Several mostly retrospective studies from Europe, the U.S. and Japan, have demonstrated a high "cure" rate, with results lending credence to the shift from surgical resection to endoscopic management of these lesions. Of concern, however, is 1) a fairly high overall complication rate of 8-26% in prospective studies3-7, and 2) as well the persistence of residual neoplasia on follow-up endoscopy ranging from 16% to 46%3, 6, 8. The former is the main topic of the present study.\n\nSevere complications including bleeding associated with a standard diagnostic or screening colonoscopy, which may include resection of predominantly smaller polyps, are uncommon. Significant bleeding occurs in 0.2 to 0.5% of patients (defined as a 2mg drop in Hemoglobin) 9, 10. The risk of severe complications increases with polyp size; here, again, the most common complication is bleeding reported in 2 to 24% of polyp resections. In one recent analysis the rate of delayed bleeding in colonic EMR was 7.5%1.\n\nIn addition to size, other factors may affect complications. These include type of resection (piecemeal versus en-bloc), polyp location (right colon with a thinner wall than the left colon), age and comorbidities, especially those that affect clotting abilities (e.g. renal insufficiency, liver disease, use of anticoagulation). Studies that have examined variables, which may directly decrease the risk of complications associated with large polyp resection, are limited.\n\nIt is apparent that resection of a large polyp leaves behind a large mucosal defect. The mucosal ulcer that forms after polyp resection can take several weeks to heal. Bleeding complications typically occur within 7 to 10 days, requiring often admission, a repeat colonoscopy to stop bleeding, and possible blood transfusions. The rates depend on size, and have been shown to be around 1.5%-2.6% overall. It is significantly higher in larger adenomas of 2 cm and more, namely 6.5% in another recent meta analysis.\n\nTo reduce the risk of bleeding various measures have been proposed which also have been summarized in several recent meta analyses. These include coagulation, clipping and others, but only few randomized trials are available: Coagulation not effective in a recent meta analysis14, but only 4 of the 12 studies were randomized and these included all mostly smaller polyps or polyps of all sizes or pedunculated polyps. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.\n\nOur primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a ≥20mm colon non-pedunculated polyp who are undergoing an ESD or EMR resection\n* signed Informed Consent\n\nExclusion Criteria:\n\n* Patients with known (biopsy proven) or strongly suspected invasive carcinoma in a potential study polyp\n* Pedunculated polyps (as defined by Paris Classification type Ip or Isp)\n* ulcerated depressed lesions (as defined by Paris Classification type III)\n* polyposis syndromes\n* inflammatory bowel disease\n* emergency colonoscopy\n* Poor general health (ASA (American Society of Anaesthesiologists) class\\>3)\n* Patients with coagulopathy with an elevated International Normalized Ratio (INR )≥1.5, or platelets \\<50\n* Poor bowel preparation\n* pregnancy or breastfeeding\n* Intervention planned using ORISE™ (Boston Medical) or LIFTUP™ (Ovesco) as lifting agents'}, 'identificationModule': {'nctId': 'NCT05029934', 'acronym': 'EndoClot™', 'briefTitle': 'Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.', 'orgStudyIdInfo': {'id': 'PV7200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EndoClot group', 'description': 'patients who are being provided with EndoClot adhesive spray after polyp resection', 'interventionNames': ['Procedure: use of EndoClot']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'no further prophylactic bleeding prevention after polyp resection', 'interventionNames': ['Procedure: use of EndoClot']}], 'interventions': [{'name': 'use of EndoClot', 'type': 'PROCEDURE', 'description': 'deployment of EndoClot adhesive spray', 'armGroupLabels': ['Control group', 'EndoClot group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12099', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Auguste-Viktoria-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Hospital Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22359', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Evangelisches Amalie Sieveking Krankenhaus', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'UKGM Marburg, Klinik für Gastroenterologie', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Klinikum Südstadt Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}