Submucosal Tumor Removal by Endoscopic Excision Therapy

NCT04913077 | Suspended

• 1 other identifier: PV7129
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Smaller submucosal tumors (SMT) in the stomach are usually seen as an incidental finding during a gastroscopy, although current diagnostics usually do not clearly indicate what type of tumor it is. In summary, there is no good evidence for dealing with SMT. In this study, an endoscopic full-thickness resection, primarily with the FTRD device, is to be offered to all patients with gastric SMT without a confirmed histology seen in a certain period of time . Patients who do not want to take advantage of this are included in a systematic follow-up program. The investigators hope to learn about the rate of so-called GIST tumors and other histologies, as well as the rate of change in the follow-up group. Also, study contents will be accuracy of endosonographic imaging and puncture in comparison with resection histology, technical feasibility and histological completeness of the FTRD- based endoscopic (full-wall) resection option, complications of such a resection (secondary bleeding and dehiscences), and patient preferences with standardized information.

Conditions

Submucosal Tumor of Stomach

Keywords

Submucosal Tumor of Stomach; GIST; FTRD

Outcome Measures

Primary Outcomes (1)

• Rate of GIST tumors

  Rate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known

  through study completion, approximately 2 years

Secondary Outcomes (10)

• Technical success

  through study completion, approximately 2 years

• Complication rate

  through study completion, approximately 2 years

• influencing factors on the GIST rate: tumor size

  through study completion, approximately 2 years

• Influencing factors on the GIST rate: position of tumor

  through study completion, approximately 2 years

• Influencing factors on the GIST rate: endoscopic ultrasound image

  through study completion, approximately 2 years

Study Arms (1)

Removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)

OTHER

FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD

Other: removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)

Interventions

removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) OTHER

FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD

Also known as: Endoscopic submucosal dissection (ESD)

Removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)

Eligibility Criteria

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

You may qualify if:

• Patients with endoscopically diagnosed and endosonographically confirmed submucosal tumors of 0.5 to 2 cm in the stomach without definitive histology / cytology
• Initial diagnosis less than 2 years ago
• No contraindication to endoscopic resection
• Patient's informed consent

You may not qualify if:

• Tumor size \> 2 cm
• Tumors with proven / suspected malignancy for which oncologically no endoscopic resection should be performed, i.e. for which oncological or surgical therapy is planned
• SMT known \> 2 Years
• Patients with severe general illnesses (limited operability) or malignancies
• Clotting disorders
• Pregnancy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Ovesco Endoscopy AG: collaborator

Study Sites (3)

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Hamburg Eppendorf

Hamburg, 20246, Germany

Location

University Hospital Marburg

Marburg, 35039, Germany

Location

Related Publications (13)

• Cai MY, Martin Carreras-Presas F, Zhou PH. Endoscopic full-thickness resection for gastrointestinal submucosal tumors. Dig Endosc. 2018 Apr;30 Suppl 1:17-24. doi: 10.1111/den.13003.

  PMID: 29658639 BACKGROUND

• Akahoshi K, Oya M, Koga T, Shiratsuchi Y. Current clinical management of gastrointestinal stromal tumor. World J Gastroenterol. 2018 Jul 14;24(26):2806-2817. doi: 10.3748/wjg.v24.i26.2806.

  PMID: 30018476 BACKGROUND

• Cazacu IM, Luzuriaga Chavez AA, Nogueras Gonzalez GM, Saftoiu A, Bhutani MS. Malignant Transformation of Ectopic Pancreas. Dig Dis Sci. 2019 Mar;64(3):655-668. doi: 10.1007/s10620-018-5366-z. Epub 2018 Nov 10.

  PMID: 30415408 BACKGROUND

• Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.

  PMID: 28385194 BACKGROUND

• Kida M, Kawaguchi Y, Miyata E, Hasegawa R, Kaneko T, Yamauchi H, Koizumi S, Okuwaki K, Miyazawa S, Iwai T, Kikuchi H, Watanabe M, Imaizumi H, Koizumi W. Endoscopic ultrasonography diagnosis of subepithelial lesions. Dig Endosc. 2017 May;29(4):431-443. doi: 10.1111/den.12854. Epub 2017 Apr 6.

  PMID: 28258621 BACKGROUND

• Kim SY, Kim KO. Management of gastric subepithelial tumors: The role of endoscopy. World J Gastrointest Endosc. 2016 Jun 10;8(11):418-24. doi: 10.4253/wjge.v8.i11.418.

  PMID: 27298713 BACKGROUND

• Kim SY, Kim KO. Endoscopic Treatment of Subepithelial Tumors. Clin Endosc. 2018 Jan;51(1):19-27. doi: 10.5946/ce.2018.020. Epub 2018 Jan 31.

  PMID: 29397653 BACKGROUND

• Lim TW, Choi CW, Kang DH, Kim HW, Park SB, Kim SJ. Endoscopic ultrasound without tissue acquisition has poor accuracy for diagnosing gastric subepithelial tumors. Medicine (Baltimore). 2016 Nov;95(44):e5246. doi: 10.1097/MD.0000000000005246.

  PMID: 27858880 BACKGROUND

• Marcella C, Shi RH, Sarwar S. Clinical Overview of GIST and Its Latest Management by Endoscopic Resection in Upper GI: A Literature Review. Gastroenterol Res Pract. 2018 Oct 31;2018:6864256. doi: 10.1155/2018/6864256. eCollection 2018.

  PMID: 30515204 BACKGROUND

• Moon JS. Role of Endoscopic Ultrasonography in Guiding Treatment Plans for Upper Gastrointestinal Subepithelial Tumors. Clin Endosc. 2016 May;49(3):220-5. doi: 10.5946/ce.2016.047. Epub 2016 May 20.

  PMID: 27209643 BACKGROUND

• Bruno M, Carucci P, Repici A, Pellicano R, Mezzabotta L, Goss M, Magnolia MR, Saracco GM, Rizzetto M, De Angelis C. The natural history of gastrointestinal subepithelial tumors arising from muscularis propria: an endoscopic ultrasound survey. J Clin Gastroenterol. 2009 Oct;43(9):821-5. doi: 10.1097/MCG.0b013e31818f50b8.

  PMID: 19349904 BACKGROUND

• Kim MY, Jung HY, Choi KD, Song HJ, Lee JH, Kim DH, Choi KS, Lee GH, Kim JH. Natural history of asymptomatic small gastric subepithelial tumors. J Clin Gastroenterol. 2011 Apr;45(4):330-6. doi: 10.1097/MCG.0b013e318206474e.

  PMID: 21278578 BACKGROUND

• Kushnir VM, Keswani RN, Hollander TG, Kohlmeier C, Mullady DK, Azar RR, Murad FM, Komanduri S, Edmundowicz SA, Early DS. Compliance with surveillance recommendations for foregut subepithelial tumors is poor: results of a prospective multicenter study. Gastrointest Endosc. 2015;81(6):1378-84. doi: 10.1016/j.gie.2014.11.013. Epub 2015 Feb 7.

  PMID: 25660977 BACKGROUND

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thomas Rösch, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Submucosal gastric Tumors up to 2 centimeters of size

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: June 4, 2021
• Study Start: March 10, 2020
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)