Clinical trial NCT06435533: Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Official title: Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenomatous Polyposis Coli
Familial Adenomatous Polyposis
Duodenal Adenoma
Keywords: Familial Adenomatous Polyposis
FAP
duodenal adenoma
argon plasma coagulation
Spigelman classification stage III
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: polyp number
timeFrame: 12 months
measure: polyp size
timeFrame: 12 months
Secondary outcomes:
measure: acute haematemesis
timeFrame: 24 hours
measure: acute hemoglobin drop
timeFrame: 24 hours
measure: acute severe hemoglobin drop
timeFrame: 24 hours
measure: blood transfusion
timeFrame: 24 hours
measure: endoscopic hemostasis
timeFrame: 24 hours
measure: treatment of perforation
timeFrame: 24 hours
measure: need for surgical intervention
timeFrame: 24 hours
measure: acute abdominal pain
timeFrame: 24 hours
measure: acute dysphagia
timeFrame: 24 hours
measure: acute rise of temperature
timeFrame: 24 hours
measure: EGD (esophago-gastro-duodenoscopy) time
timeFrame: during EGD; up to 45 minutes
measure: therapy time
timeFrame: up to 30 minutes
measure: abdominal pain
timeFrame: 4 days
measure: nausea
timeFrame: 4 days
measure: feeling of fullness
timeFrame: 4 days
measure: emesis
timeFrame: 4 days
measure: signs of bleeding
timeFrame: 4 days
measure: fever
timeFrame: 4 days
measure: need for physician help
timeFrame: 4 days
measure: success rate
timeFrame: 12 months
measure: dysphagia
timeFrame: 12 months
measure: balloon dilatations
timeFrame: 12 months
measure: abdominal pain
timeFrame: 12 months
measure: postprandial pain
timeFrame: 12 months
measure: emesis
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Universitätskrankenhaus Hamburg-Eppendorf
name: Thomas Rösch, Professor
role: PRINCIPAL_INVESTIGATOR
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