Submucosal Tumor of StomachSTREETNCT04913077
Submucosal Tumor Removal by Endoscopic Excision Therapy
A study testing removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) in people with Submucosal Tumor of Stomach, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Submucosal Tumor of Stomach
- What is being tested?
- removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- 10 Mar 2020to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Freiburg
Freiburg im Breisgau, 79106
University Hospital Hamburg Eppendorf
Hamburg, 20246
University Hospital Marburg
Marburg, 35039
About this study
Official title: Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)
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.
Read the detailed description
Smaller submucous tumors in the stomach are usually seen as a random finding in gastroscopies and present a diagnostic dilemma to the doctor and patient:
type specification is usually unclear whether it is an absolutely benign (without degeneration potential) or a malignant or prone tumor (usually gastrointestinal stromal tumor, GIST). However, this is crucial for further management.
In endosonographic imaging there are only approximate values in the differential diagnosis between GIST and non-GIST, the endoscopic biopsy is too superficial, and the hit rate of endosonographic pin puncture is limited, and in most studies is less than 70% Therefore, one can only make assumptions and create a risk profile from imaging and tumor size (limit size 3 cm, partly also 2 cm). Both follow-up recommendations (rather no GIST) and laparoscopic surgical removal (proven or probable/possible GIST) are not rarely without clear preference, especially for smaller tumors.
For these indications, a simple endoscopic removal option comparable to the polypectomy in the colon (where no histological type diagnosis is made before) does not exist.
Previous studies are usually subject to bias in several directions:
- The frequency of GIST tumors among submucous tumors/lesions (SMT) in the stomach is unclear. Gastroenterological series always contain smaller GIST tumors, but are reported almost exclusively from clinics. The rate of these tumors in the overall collective of patients seen in the field of (mostly established) gastroenterologists is thus completely unclear. Surgical or oncological series have usually included more aggressive tumors consisting mainly or exclusively of GIST tumors, therefore do not allow epidemiological conclusions.
- If no surgery is performed (and thus a definitive histology is forced), only information from follow-up examinations remains. Previous follow-up studies show the dilemma of insufficient differential diagnosis of lesions by endosonography and (endosonographic or other) biopsy, which usually have insufficient accuracy. In addition, the follow-up time in the studies hardly extends beyond 2 years. The "gastroenterological gut instinct" that these small lesions are not dangerous may be true, but is not proven.
- Conditions
- Submucosal Tumor of Stomach
- Being tested
- removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)
- Keywords
- Submucosal Tumor of Stomach, GIST, FTRD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)Other
Also called Endoscopic submucosal dissection (ESD)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, approximately 2 years
Secondary outcomes (10)
Technical success
Technical success rate (R0/R1 resection) of the chosen resection technique
Measured: through study completion, approximately 2 years
Complication rate
Complication rate of the chosen resection technique
Measured: through study completion, approximately 2 years
influencing factors on the GIST rate: tumor size
Influence of tumor size on the GIST rate
Measured: through study completion, approximately 2 years
Influencing factors on the GIST rate: position of tumor
Influence of tumor position in the stomach
Measured: through study completion, approximately 2 years
Influencing factors on the GIST rate: endoscopic ultrasound image
endoscopic ultrasound image with pattern and position in the wall
Measured: through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's age
Age of patients
Measured: through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's gender
gender of patients
Measured: through study completion, approximately 2 years
Influencing factors on the GIST rate: anamnesis
anamnesis including initial diagnosis
Measured: through study completion, approximately 2 years
Patient's preferred approach
Patient preferences for removal (consent rate for the study) versus follow-up
Measured: through study completion, approximately 2 years
data for cost-benefit calculation
Establishment of a date base for a cost-benefit calculation comparing follow-up vs. removal
Measured: through study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start10 Mar 2020
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Submucosal Tumor of StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Submucosal gastric Tumors up to 2 centimeters of size
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Responsible party
- Sponsor
- Investigators
- Thomas Rösch, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913077
- Sponsor's protocol ID
- PV7129
- Acronym
- STREET
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29658639Akahoshi 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.
PubMed 30018476Cazacu 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.
PubMed 30415408Standards 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.
PubMed 28385194Kida 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.
PubMed 28258621Kim 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.
PubMed 27298713Kim 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.
PubMed 29397653Lim 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.
PubMed 27858880Marcella 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.
PubMed 30515204Moon 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.
PubMed 27209643Bruno 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.
PubMed 19349904Kim 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.
PubMed 21278578Kushnir 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.
PubMed 25660977
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)
- ClinicalTrials.gov ID
- NCT04913077
- Acronym / sponsor ID
- STREET / PV7129
- Conditions
- Submucosal Tumor of Stomach
- Keywords
- Submucosal Tumor of Stomach, GIST, FTRD
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: interim analysis
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Smaller submucous tumors in the stomach are usually seen as a random finding in gastroscopies and present a diagnostic dilemma to the doctor and patient:
type specification is usually unclear whether it is an absolutely benign (without degeneration potential) or a malignant or prone tumor (usually gastrointestinal stromal tumor, GIST). However, this is crucial for further management.
In endosonographic imaging there are only approximate values in the differential diagnosis between GIST and non-GIST, the endoscopic biopsy is too superficial, and the hit rate of endosonographic pin puncture is limited, and in most studies is less than 70% Therefore, one can only make assumptions and create a risk profile from imaging and tumor size (limit size 3 cm, partly also 2 cm). Both follow-up recommendations (rather no GIST) and laparoscopic surgical removal (proven or probable/possible GIST) are not rarely without clear preference, especially for smaller tumors.
For these indications, a simple endoscopic removal option comparable to the polypectomy in the colon (where no histological type diagnosis is made before) does not exist.
Previous studies are usually subject to bias in several directions:
- The frequency of GIST tumors among submucous tumors/lesions (SMT) in the stomach is unclear. Gastroenterological series always contain smaller GIST tumors, but are reported almost exclusively from clinics. The rate of these tumors in the overall collective of patients seen in the field of (mostly established) gastroenterologists is thus completely unclear. Surgical or oncological series have usually included more aggressive tumors consisting mainly or exclusively of GIST tumors, therefore do not allow epidemiological conclusions.
- If no surgery is performed (and thus a definitive histology is forced), only information from follow-up examinations remains. Previous follow-up studies show the dilemma of insufficient differential diagnosis of lesions by endosonography and (endosonographic or other) biopsy, which usually have insufficient accuracy. In addition, the follow-up time in the studies hardly extends beyond 2 years. The "gastroenterological gut instinct" that these small lesions are not dangerous may be true, but is not proven.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Submucosal gastric Tumors up to 2 centimeters of size
| Arm | Type | Receives |
|---|---|---|
| Removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) | Other | Other: removal of submucosal gastric tumor preferably by Full Thickness Resection Device (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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)Also: Endoscopic submucosal dissection (ESD)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) |
Primary outcome
Rate of GIST tumors
Time frame: through study completion, approximately 2 years
Rate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known
10 secondary outcomes
Technical success
Time frame: through study completion, approximately 2 years
Complication rate
Time frame: through study completion, approximately 2 years
influencing factors on the GIST rate: tumor size
Time frame: through study completion, approximately 2 years
Influencing factors on the GIST rate: position of tumor
Time frame: through study completion, approximately 2 years
Influencing factors on the GIST rate: endoscopic ultrasound image
Time frame: through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's age
Time frame: through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's gender
Time frame: through study completion, approximately 2 years
Influencing factors on the GIST rate: anamnesis
Time frame: through study completion, approximately 2 years
Patient's preferred approach
Time frame: through study completion, approximately 2 years
data for cost-benefit calculation
Time frame: through study completion, approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 29658639Cai 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.
- Background: PubMed 30018476Akahoshi 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.
- Background: PubMed 30415408Cazacu 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.
- Background: PubMed 28385194Standards 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.
- Background: PubMed 28258621Kida 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.
- Background: PubMed 27298713Kim 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.
- Background: PubMed 29397653Kim 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.
- Background: PubMed 27858880Lim 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.
- Background: PubMed 30515204Marcella 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.
- Background: PubMed 27209643Moon 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.
- Background: PubMed 19349904Bruno 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.
- Background: PubMed 21278578Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Rösch, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) in people with Submucosal Tumor of Stomach, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of GIST tumors (time frame: through study completion, approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913077, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.