Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis

NCT06435533 | Recruiting

• 1 other identifier: 2023-101193-BO-ff
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenomatous Polyposis Coli; Familial Adenomatous Polyposis; Duodenal Adenoma

Keywords

Familial Adenomatous Polyposis; FAP; duodenal adenoma; argon plasma coagulation; Spigelman classification stage III

Outcome Measures

Primary Outcomes (2)

• polyp number

  Significant reduction in the number of duodenal polyps at the next follow-up appointment

  12 months

• polyp size

  Significant reduction in the size of duodenal polyps at the next follow-up appointment

  12 months

Secondary Outcomes (25)

• acute haematemesis

  24 hours

• acute hemoglobin drop

  24 hours

• acute severe hemoglobin drop

  24 hours

• blood transfusion

  24 hours

• endoscopic hemostasis

  24 hours

Study Arms (1)

duodenal polyps <10 mm

EXPERIMENTAL

low energy argonplasma coagulation

Device: low energy argonplasma coagulation

Interventions

low energy argonplasma coagulation DEVICE

see above

Also known as: cold APC

duodenal polyps <10 mm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed FAP disease
• duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
• presence of duodenal polyps \< 10 mm
• written Informed Consent

You may not qualify if:

• presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
• pregnancy or breastfeeding
• severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year
• severe coagulopathy
• any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (24)

• 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: 35988966 BACKGROUND

• 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: 19822006 BACKGROUND

• 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: 28490611 BACKGROUND

• 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: 14960520 BACKGROUND

• 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: 11355321 BACKGROUND

• 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: 11677205 BACKGROUND

• 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: 31342472 BACKGROUND

• 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: 2571019 BACKGROUND

• 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: 37389449 BACKGROUND

• Manner H. Argon plasma coagulation therapy. Curr Opin Gastroenterol. 2008 Sep;24(5):612-6. doi: 10.1097/MOG.0b013e32830bf825.

  PMID: 19122503 BACKGROUND

• 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: 35883753 BACKGROUND

• 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: 35454839 BACKGROUND

• 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: 8081915 BACKGROUND

• 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: 19440956 BACKGROUND

• 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: 34408826 BACKGROUND

• 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: 24013107 BACKGROUND

• 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: 17497979 BACKGROUND

• 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: 16702032 BACKGROUND

• 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: 21960285 BACKGROUND

• 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: 32516770 BACKGROUND

• 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: 18565020 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 37575136 BACKGROUND

Related Links

• German oncological guidelines for colorectal cancer

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Rösch, Professor

  Universitätskrankenhaus Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Rösch, Professor

CONTACT

+49407410; t.roesch@uke.de

Tania Ruppenthal

CONTACT

+49407410; t.ruppenthal@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf

Model Details: peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: May 30, 2024
• Study Start: December 6, 2023
• Primary Completion: January 30, 2025
• Study Completion: March 2, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

DE (1)