Clinical trial · Interventional
Submucosal Tumor Removal by Endoscopic Excision Therapy
Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): interim analysis
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Submucosal Tumor of Stomach | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)
- description
- 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
- interventionNames
- Other: removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)
Primary outcomes (1)
- measure
- Rate of GIST tumors
- timeFrame
- through study completion, approximately 2 years
- description
- Rate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (13)
- BACKGROUNDCai 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
- BACKGROUNDAkahoshi 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
- BACKGROUNDCazacu 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
- BACKGROUNDStandards 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
- BACKGROUNDKida 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
- BACKGROUNDKim 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
- BACKGROUNDKim 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.