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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.
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.
In 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.
The 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.
Regarding current knowledge this is the first application of this APC modality in the GI tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| duodenal polyps <10 mm | Experimental | low energy argonplasma coagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low energy argonplasma coagulation | Device | see above |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| acute haematemesis | rate of acute adverse incidents: bleeding | 24 hours |
| acute hemoglobin drop | rate of acute adverse incidents: Hb drop < 2g /dl (grammes per decilitre) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Rösch, Professor | Contact | +49407410 | 50098 | t.roesch@uke.de |
| Tania Ruppenthal | Contact | +49407410 | 50089 | t.ruppenthal@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Rösch, Professor | Universitätskrankenhaus Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35988966 | Background | 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. | |
| 19822006 | 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. |
| Label | URL |
|---|---|
| German oncological guidelines for colorectal cancer | View source |
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peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
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| 24 hours |
| acute severe hemoglobin drop | rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre) | 24 hours |
| blood transfusion | rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre) | 24 hours |
| endoscopic hemostasis | rate of acute adverse incidents: coagulation or clipping | 24 hours |
| treatment of perforation | rate of acute adverse incidents: endoscopic clipping | 24 hours |
| need for surgical intervention | rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment | 24 hours |
| acute abdominal pain | rate of acute adverse incidents:pain | 24 hours |
| acute dysphagia | rate of acute adverse incidents: stenosis | 24 hours |
| acute rise of temperature | rate of acute adverse incidents: fever <38°C (degrees Centigrade) | 24 hours |
| EGD (esophago-gastro-duodenoscopy) time | total EGD performing time | during EGD; up to 45 minutes |
| therapy time | total ablation time in minutes | up to 30 minutes |
| abdominal pain | abdominal pain assessed by patient survey | 4 days |
| nausea | nausea assessed by patient survey | 4 days |
| feeling of fullness | feeling of fullness assessed by patient survey | 4 days |
| emesis | emesis assessed by patient survey | 4 days |
| signs of bleeding | hematemesis or tar faeces assessed by patient survey | 4 days |
| fever | fever >38°C | 4 days |
| need for physician help | visits in doctor's office or hospital | 4 days |
| success rate | Change in stage/number of points in Spigelman classification compared to the previous examination | 12 months |
| dysphagia | dysphagia caused by duodenal stricture | 12 months |
| balloon dilatations | need for endoscopic dilatation of strictured duodenum | 12 months |
| abdominal pain | general abdominal pain assessed by patient survey | 12 months |
| postprandial pain | postprandial abdominal pain assessed by patient survey | 12 months |
| emesis | regurgitation due to duodenal strictures assessed by EGD | 12 months |
| 28490611 | 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. |
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| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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