## Protocol Section
### Identification Module
**NCT ID:** NCT06435533

**Acronym:** coldAPC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2023-101193-BO-ff
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2025-03-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsklinikum Hamburg-Eppendorf

#### Responsible Party

**Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf

**Investigator Full Name:** Prof. Dr. Thomas Rösch

**Investigator Title:** Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Adenomatous Polyposis Coli

- Familial Adenomatous Polyposis

- Duodenal Adenoma

**Keywords:**

- Familial Adenomatous Polyposis

- FAP

- duodenal adenoma

- argon plasma coagulation

- Spigelman classification stage III

### Design Module

#### Design Info

**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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** low energy argonplasma coagulation

**Intervention Names:**

- Device: low energy argonplasma coagulation

**Label:** duodenal polyps <10 mm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- duodenal polyps <10 mm

**Description:** see above

**Name:** low energy argonplasma coagulation

**Other Names:**

- cold APC

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** polyp number

**Time Frame:** 12 months

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

**Measure:** polyp size

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** rate of acute adverse incidents: bleeding

**Measure:** acute haematemesis

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: Hb drop \< 2g /dl (grammes per decilitre)

**Measure:** acute hemoglobin drop

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)

**Measure:** acute severe hemoglobin drop

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)

**Measure:** blood transfusion

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: coagulation or clipping

**Measure:** endoscopic hemostasis

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: endoscopic clipping

**Measure:** treatment of perforation

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment

**Measure:** need for surgical intervention

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents:pain

**Measure:** acute abdominal pain

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: stenosis

**Measure:** acute dysphagia

**Time Frame:** 24 hours

**Description:** rate of acute adverse incidents: fever \<38°C (degrees Centigrade)

**Measure:** acute rise of temperature

**Time Frame:** 24 hours

**Description:** total EGD performing time

**Measure:** EGD (esophago-gastro-duodenoscopy) time

**Time Frame:** during EGD; up to 45 minutes

**Description:** total ablation time in minutes

**Measure:** therapy time

**Time Frame:** up to 30 minutes

**Description:** abdominal pain assessed by patient survey

**Measure:** abdominal pain

**Time Frame:** 4 days

**Description:** nausea assessed by patient survey

**Measure:** nausea

**Time Frame:** 4 days

**Description:** feeling of fullness assessed by patient survey

**Measure:** feeling of fullness

**Time Frame:** 4 days

**Description:** emesis assessed by patient survey

**Measure:** emesis

**Time Frame:** 4 days

**Description:** hematemesis or tar faeces assessed by patient survey

**Measure:** signs of bleeding

**Time Frame:** 4 days

**Description:** fever \>38°C

**Measure:** fever

**Time Frame:** 4 days

**Description:** visits in doctor's office or hospital

**Measure:** need for physician help

**Time Frame:** 4 days

**Description:** Change in stage/number of points in Spigelman classification compared to the previous examination

**Measure:** success rate

**Time Frame:** 12 months

**Description:** dysphagia caused by duodenal stricture

**Measure:** dysphagia

**Time Frame:** 12 months

**Description:** need for endoscopic dilatation of strictured duodenum

**Measure:** balloon dilatations

**Time Frame:** 12 months

**Description:** general abdominal pain assessed by patient survey

**Measure:** abdominal pain

**Time Frame:** 12 months

**Description:** postprandial abdominal pain assessed by patient survey

**Measure:** postprandial pain

**Time Frame:** 12 months

**Description:** regurgitation due to duodenal strictures assessed by EGD

**Measure:** emesis

**Time Frame:** 12 months

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** t.roesch@uke.de

**Name:** Thomas Rösch, Professor

**Phone:** +49407410

**Phone Ext:** 50098

**Role:** CONTACT

**Contact 2:**

**Email:** t.ruppenthal@uke.de

**Name:** Tania Ruppenthal

**Phone:** +49407410

**Phone Ext:** 50089

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamburg

**Contacts:**

***Contact 1:***

- **Email:** t.roesch@uke.de

- **Name:** Thomas Rösch, Professor

- **Phone:** +49407410

- **Phone Ext:** 50098

- **Role:** CONTACT

***Contact 2:***

- **Email:** t.ruppenthal@uke.de

- **Name:** Tania Ruppenthal

- **Phone:** +49407410

- **Phone Ext:** 50089

- **Role:** CONTACT

***Contact 3:***

- **Name:** Thomas Rösch, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Jocelyn de Heer, PD Dr.

- **Role:** SUB_INVESTIGATOR

**Country:** Germany

**Facility:** University Hospital Hamburg-Eppendorf

**Status:** RECRUITING

**Zip:** 20246

#### Overall Officials

**Official 1:**

**Affiliation:** Universitätskrankenhaus Hamburg-Eppendorf

**Name:** Thomas Rösch, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

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**PMID:** 35988966

**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:** 19822006

**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:** 28490611

**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:** 14960520

**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:** 11355321

**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:** 11677205

**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:** 31342472

**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:** 2571019

**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:** 37389449

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

**PMID:** 19122503

**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:** 35883753

**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:** 35454839

**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:** 8081915

**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:** 19440956

**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:** 34408826

**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:** 24013107

**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:** 17497979

**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:** 16702032

**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:** 21960285

**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.

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**PMID:** 37575136

#### See Also Links

**Label:** German oncological guidelines for colorectal cancer

**URL:** http://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000010610

- Term: Pharyngeal Neoplasms

- ID: D000010039

- Term: Otorhinolaryngologic Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000009302

- Term: Nasopharyngeal Diseases

- ID: D000010608

- Term: Pharyngeal Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000018256

- Term: Adenomatous Polyps

- ID: D000009386

- Term: Neoplastic Syndromes, Hereditary

- ID: D000044483

- Term: Intestinal Polyposis

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3591

- Name: Adenoma

- Relevance: HIGH

- As Found: Adenoma

- ID: M14009

- Name: Adenomatous Polyposis Coli

- Relevance: HIGH

- As Found: Familial Adenomatous Polyposis

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14011

- Name: Polyps

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Polyposis

- ID: M12254

- Name: Nasopharyngeal Neoplasms

- Relevance: HIGH

- As Found: Polyposis

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13517

- Name: Pharyngeal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12962

- Name: Otorhinolaryngologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12253

- Name: Nasopharyngeal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13515

- Name: Pharyngeal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20402

- Name: Adenomatous Polyps

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12331

- Name: Neoplastic Syndromes, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M25346

- Name: Intestinal Polyposis

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T2191

- Name: Familial Adenomatous Polyposis

- Relevance: HIGH

- As Found: Familial Adenomatous Polyposis

- ID: T4001

- Name: MYH-associated Polyposis

- Relevance: HIGH

- As Found: Familial Adenomatous Polyposis

### Condition Browse Module - Meshes

- ID: D000000236

- Term: Adenoma

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000009303

- Term: Nasopharyngeal Neoplasms

- ID: D000011125

- Term: Adenomatous Polyposis Coli

### Misc Info Module

- Version Holder: 2024-05-31
