Sponsor study identifier
interventional
200
1 country
3
Study Start
March 10, 2020
Actual (reported)Primary Completion
November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2020
Actual (reported)January 23, 2021
Actual (reported)June 4, 2021
Actual (reported)November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Freiburg
Freiburg im Breisgau, 79106, Germany
University Hospital Hamburg Eppendorf
Hamburg, 20246, Germany
University Hospital Marburg
Marburg, 35039, Germany
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.
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.
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.
Thomas Rösch, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
First Submitted
January 23, 2021
First Posted
June 4, 2021
Study Start
March 10, 2020
Actual (reported)Primary Completion
November 2024
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 19, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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