Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT06435533
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}], 'ancestors': [{'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': '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': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'polyp number', 'timeFrame': '12 months', 'description': 'Significant reduction in the number of duodenal polyps at the next follow-up appointment'}, {'measure': 'polyp size', 'timeFrame': '12 months', 'description': 'Significant reduction in the size of duodenal polyps at the next follow-up appointment'}], 'secondaryOutcomes': [{'measure': 'acute haematemesis', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: bleeding'}, {'measure': 'acute hemoglobin drop', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: Hb drop \\< 2g /dl (grammes per decilitre)'}, {'measure': 'acute severe hemoglobin drop', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: Hb drop = or \\> 2g /dl (grammes per decilitre)'}, {'measure': 'blood transfusion', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: Hb drop = or \\> 2g /dl (grammes per decilitre)'}, {'measure': 'endoscopic hemostasis', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: coagulation or clipping'}, {'measure': 'treatment of perforation', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: endoscopic clipping'}, {'measure': 'need for surgical intervention', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment'}, {'measure': 'acute abdominal pain', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents:pain'}, {'measure': 'acute dysphagia', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: stenosis'}, {'measure': 'acute rise of temperature', 'timeFrame': '24 hours', 'description': 'rate of acute adverse incidents: fever \\<38°C (degrees Centigrade)'}, {'measure': 'EGD (esophago-gastro-duodenoscopy) time', 'timeFrame': 'during EGD; up to 45 minutes', 'description': 'total EGD performing time'}, {'measure': 'therapy time', 'timeFrame': 'up to 30 minutes', 'description': 'total ablation time in minutes'}, {'measure': 'abdominal pain', 'timeFrame': '4 days', 'description': 'abdominal pain assessed by patient survey'}, {'measure': 'nausea', 'timeFrame': '4 days', 'description': 'nausea assessed by patient survey'}, {'measure': 'feeling of fullness', 'timeFrame': '4 days', 'description': 'feeling of fullness assessed by patient survey'}, {'measure': 'emesis', 'timeFrame': '4 days', 'description': 'emesis assessed by patient survey'}, {'measure': 'signs of bleeding', 'timeFrame': '4 days', 'description': 'hematemesis or tar faeces assessed by patient survey'}, {'measure': 'fever', 'timeFrame': '4 days', 'description': 'fever \\>38°C'}, {'measure': 'need for physician help', 'timeFrame': '4 days', 'description': "visits in doctor's office or hospital"}, {'measure': 'success rate', 'timeFrame': '12 months', 'description': 'Change in stage/number of points in Spigelman classification compared to the previous examination'}, {'measure': 'dysphagia', 'timeFrame': '12 months', 'description': 'dysphagia caused by duodenal stricture'}, {'measure': 'balloon dilatations', 'timeFrame': '12 months', 'description': 'need for endoscopic dilatation of strictured duodenum'}, {'measure': 'abdominal pain', 'timeFrame': '12 months', 'description': 'general abdominal pain assessed by patient survey'}, {'measure': 'postprandial pain', 'timeFrame': '12 months', 'description': 'postprandial abdominal pain assessed by patient survey'}, {'measure': 'emesis', 'timeFrame': '12 months', 'description': 'regurgitation due to duodenal strictures assessed by EGD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Familial Adenomatous Polyposis', 'FAP', 'duodenal adenoma', 'argon plasma coagulation', 'Spigelman classification stage III'], 'conditions': ['Adenomatous Polyposis Coli', 'Familial Adenomatous Polyposis', 'Duodenal Adenoma']}, 'referencesModule': {'references': [{'pmid': '35988966', 'type': 'BACKGROUND', 'citation': 'Aelvoet AS, Buttitta F, Ricciardiello L, Dekker E. Management of familial adenomatous polyposis and MUTYH-associated polyposis; new insights. Best Pract Res Clin Gastroenterol. 2022 Jun-Aug;58-59:101793. doi: 10.1016/j.bpg.2022.101793. Epub 2022 Mar 16.'}, {'pmid': '19822006', 'type': 'BACKGROUND', 'citation': 'Half E, Bercovich D, Rozen P. Familial adenomatous polyposis. Orphanet J Rare Dis. 2009 Oct 12;4:22. doi: 10.1186/1750-1172-4-22.'}, {'pmid': '28490611', 'type': 'BACKGROUND', 'citation': 'Ghorbanoghli Z, Bastiaansen BA, Langers AM, Nagengast FM, Poley JW, Hardwick JC, Koornstra JJ, Sanduleanu S, de Vos Tot Nederveen Cappel WH, Witteman BJ, Morreau H, Dekker E, Vasen HF. Extracolonic cancer risk in Dutch patients with APC (adenomatous polyposis coli)-associated polyposis. J Med Genet. 2018 Jan;55(1):11-14. doi: 10.1136/jmedgenet-2017-104545. Epub 2017 May 10.'}, {'pmid': '14960520', 'type': 'BACKGROUND', 'citation': 'Bulow S, Bjork J, Christensen IJ, Fausa O, Jarvinen H, Moesgaard F, Vasen HF; DAF Study Group. Duodenal adenomatosis in familial adenomatous polyposis. Gut. 2004 Mar;53(3):381-6. doi: 10.1136/gut.2003.027771.'}, {'pmid': '11355321', 'type': 'BACKGROUND', 'citation': 'Kadmon M, Tandara A, Herfarth C. Duodenal adenomatosis in familial adenomatous polyposis coli. A review of the literature and results from the Heidelberg Polyposis Register. Int J Colorectal Dis. 2001 Apr;16(2):63-75. doi: 10.1007/s003840100290.'}, {'pmid': '11677205', 'type': 'BACKGROUND', 'citation': 'Bjork J, Akerbrant H, Iselius L, Bergman A, Engwall Y, Wahlstrom J, Martinsson T, Nordling M, Hultcrantz R. Periampullary adenomas and adenocarcinomas in familial adenomatous polyposis: cumulative risks and APC gene mutations. Gastroenterology. 2001 Nov;121(5):1127-35. doi: 10.1053/gast.2001.28707.'}, {'pmid': '31342472', 'type': 'BACKGROUND', 'citation': 'van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.'}, {'pmid': '2571019', 'type': 'BACKGROUND', 'citation': 'Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5. doi: 10.1016/s0140-6736(89)90840-4.'}, {'pmid': '37389449', 'type': 'BACKGROUND', 'citation': 'Manner H. Thermal ablative therapies in the gastrointestinal tract. Curr Opin Gastroenterol. 2023 Sep 1;39(5):370-374. doi: 10.1097/MOG.0000000000000954. Epub 2023 Jun 22.'}, {'pmid': '19122503', 'type': 'BACKGROUND', 'citation': 'Manner H. Argon plasma coagulation therapy. Curr Opin Gastroenterol. 2008 Sep;24(5):612-6. doi: 10.1097/MOG.0b013e32830bf825.'}, {'pmid': '35883753', 'type': 'BACKGROUND', 'citation': 'Martusevich AK, Surovegina AV, Bocharin IV, Nazarov VV, Minenko IA, Artamonov MY. Cold Argon Athmospheric Plasma for Biomedicine: Biological Effects, Applications and Possibilities. Antioxidants (Basel). 2022 Jun 27;11(7):1262. doi: 10.3390/antiox11071262.'}, {'pmid': '35454839', 'type': 'BACKGROUND', 'citation': 'Marzi J, Stope MB, Henes M, Koch A, Wenzel T, Holl M, Layland SL, Neis F, Bosmuller H, Ruoff F, Templin M, Kramer B, Staebler A, Barz J, Carvajal Berrio DA, Enderle M, Loskill PM, Brucker SY, Schenke-Layland K, Weiss M. Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia. Cancers (Basel). 2022 Apr 12;14(8):1933. doi: 10.3390/cancers14081933.'}, {'pmid': '8081915', 'type': 'BACKGROUND', 'citation': 'Grund KE, Storek D, Farin G. Endoscopic argon plasma coagulation (APC) first clinical experiences in flexible endoscopy. Endosc Surg Allied Technol. 1994 Feb;2(1):42-6.'}, {'pmid': '19440956', 'type': 'BACKGROUND', 'citation': 'Karamanolis G, Triantafyllou K, Tsiamoulos Z, Polymeros D, Kalli T, Misailidis N, Ladas SD. Argon plasma coagulation has a long-lasting therapeutic effect in patients with chronic radiation proctitis. Endoscopy. 2009 Jun;41(6):529-31. doi: 10.1055/s-0029-1214726. Epub 2009 May 13.'}, {'pmid': '34408826', 'type': 'BACKGROUND', 'citation': 'Peng M, Guo X, Yi F, Shao X, Wang L, Wu Y, Wang C, Zhu M, Bian O, Ibrahim M, Chawla S, Qi X. Endoscopic treatment for gastric antral vascular ectasia. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211039696. doi: 10.1177/20406223211039696. eCollection 2021.'}, {'pmid': '24013107', 'type': 'BACKGROUND', 'citation': 'Swanson E, Mahgoub A, MacDonald R, Shaukat A. Medical and endoscopic therapies for angiodysplasia and gastric antral vascular ectasia: a systematic review. Clin Gastroenterol Hepatol. 2014 Apr;12(4):571-82. doi: 10.1016/j.cgh.2013.08.038. Epub 2013 Sep 5.'}, {'pmid': '17497979', 'type': 'BACKGROUND', 'citation': 'Lienert A, Bagshaw PF. Treatment of duodenal adenomas with endoscopic argon plasma coagulation. ANZ J Surg. 2007 May;77(5):371-3. doi: 10.1111/j.1445-2197.2007.04063.x.'}, {'pmid': '16702032', 'type': 'BACKGROUND', 'citation': 'Manner H, May A, Faerber M, Rabenstein T, Ell C. Safety and efficacy of a new high power argon plasma coagulation system (hp-APC) in lesions of the upper gastrointestinal tract. Dig Liver Dis. 2006 Jul;38(7):471-8. doi: 10.1016/j.dld.2006.03.022. Epub 2006 May 15.'}, {'pmid': '21960285', 'type': 'BACKGROUND', 'citation': 'Jaganmohan S, Lynch PM, Raju RP, Ross WA, Lee JE, Raju GS, Bhutani MS, Fleming JB, Lee JH. Endoscopic management of duodenal adenomas in familial adenomatous polyposis--a single-center experience. Dig Dis Sci. 2012 Mar;57(3):732-7. doi: 10.1007/s10620-011-1917-2. Epub 2011 Sep 30.'}, {'pmid': '32516770', 'type': 'BACKGROUND', 'citation': 'Na HK, Kim DH, Ahn JY, Lee JH, Jung KW, Choi KD, Song HJ, Lee GH, Jung HY. Clinical Outcomes following Endoscopic Treatment for Sporadic Nonampullary Duodenal Adenoma. Dig Dis. 2020;38(5):364-372. doi: 10.1159/000504249. Epub 2020 Jun 9.'}, {'pmid': '18565020', 'type': 'BACKGROUND', 'citation': 'Manner H, Enderle MD, Pech O, May A, Plum N, Riemann JF, Ell C, Eickhoff A. Second-generation argon plasma coagulation: two-center experience with 600 patients. J Gastroenterol Hepatol. 2008 Jun;23(6):872-8. doi: 10.1111/j.1440-1746.2008.05437.x.'}, {'pmid': '18071803', 'type': 'BACKGROUND', 'citation': 'Eickhoff A, Hartmann D, Eickhoff JC, Riemann JF, Enderle MD. Pain sensation and neuromuscular stimulation during argon plasma coagulation in gastrointestinal endoscopy. Surg Endosc. 2008 Jul;22(7):1701-7. doi: 10.1007/s00464-007-9700-3. Epub 2007 Dec 11.'}, {'pmid': '35047339', 'type': 'BACKGROUND', 'citation': 'Amoyel M, Belle A, Dhooge M, Ali EA, Hallit R, Prat F, Dohan A, Terris B, Chaussade S, Coriat R, Barret M. Endoscopic management of non-ampullary duodenal adenomas. Endosc Int Open. 2022 Jan 14;10(1):E96-E108. doi: 10.1055/a-1723-2847. eCollection 2022 Jan.'}, {'pmid': '37575136', 'type': 'BACKGROUND', 'citation': 'Kim GE, Siddiqui UD. Endoscopic Resection Techniques for Duodenal and Ampullary Adenomas. VideoGIE. 2023 Jul 22;8(8):330-335. doi: 10.1016/j.vgie.2023.05.006. eCollection 2023 Aug.'}], 'seeAlsoLinks': [{'url': 'http://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/', 'label': 'German oncological guidelines for colorectal cancer'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.', 'detailedDescription': 'Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.\n\nIn this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.\n\nThe application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.\n\nRegarding current knowledge this is the first application of this APC modality in the GI tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed FAP disease\n* duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman\n* presence of duodenal polyps \\< 10 mm\n* written Informed Consent\n\nExclusion Criteria:\n\n* presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma\n* pregnancy or breastfeeding\n* severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \\< 1 year\n* severe coagulopathy\n* any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas'}, 'identificationModule': {'nctId': 'NCT06435533', 'acronym': 'coldAPC', 'briefTitle': 'Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis', 'orgStudyIdInfo': {'id': '2023-101193-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'duodenal polyps <10 mm', 'description': 'low energy argonplasma coagulation', 'interventionNames': ['Device: low energy argonplasma coagulation']}], 'interventions': [{'name': 'low energy argonplasma coagulation', 'type': 'DEVICE', 'otherNames': ['cold APC'], 'description': 'see above', 'armGroupLabels': ['duodenal polyps <10 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Rösch, Professor', 'role': 'CONTACT', 'email': 't.roesch@uke.de', 'phone': '+49407410', 'phoneExt': '50098'}, {'name': 'Tania Ruppenthal', 'role': 'CONTACT', 'email': 't.ruppenthal@uke.de', 'phone': '+49407410', 'phoneExt': '50089'}, {'name': 'Thomas Rösch, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jocelyn de Heer, PD Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Thomas Rösch, Professor', 'role': 'CONTACT', 'email': 't.roesch@uke.de', 'phone': '+49407410', 'phoneExt': '50098'}, {'name': 'Tania Ruppenthal', 'role': 'CONTACT', 'email': 't.ruppenthal@uke.de', 'phone': '+49407410', 'phoneExt': '50089'}], 'overallOfficials': [{'name': 'Thomas Rösch, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätskrankenhaus Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf', 'investigatorFullName': 'Prof. Dr. Thomas Rösch', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}