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Trial Title:
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
NCT ID:
NCT06435533
Condition:
Adenomatous Polyposis Coli
Familial Adenomatous Polyposis
Duodenal Adenoma
Conditions: Official terms:
Adenoma
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Conditions: Keywords:
Familial Adenomatous Polyposis
FAP
duodenal adenoma
argon plasma coagulation
Spigelman classification stage III
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy
argonplasma coagulation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
low energy argonplasma coagulation
Description:
see above
Arm group label:
duodenal polyps <10 mm
Other name:
cold APC
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Rösch, Professor
Phone:
+49407410
Phone ext:
50098
Email:
t.roesch@uke.de
Contact backup:
Last name:
Tania Ruppenthal
Phone:
+49407410
Phone ext:
50089
Email:
t.ruppenthal@uke.de
Investigator:
Last name:
Thomas Rösch, Professor
Email:
Principal Investigator
Investigator:
Last name:
Jocelyn de Heer, PD Dr.
Email:
Sub-Investigator
Start date:
December 6, 2023
Completion date:
March 2, 2025
Lead sponsor:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Source:
Universitätsklinikum Hamburg-Eppendorf
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435533
http://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/
