Gastric GISTNCT03722056
Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach
An observational study of Gastric GIST and Submucosal Tumor of Stomach, run by GEM Hospital & Research Center.
Trial summary
Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric GIST, Submucosal Tumor of Stomach
- What is being tested?
- Laparoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with suspected Gastric GIST with size more than 2 cm
Who may be able to join
- Gastric GIST>2cm size
Who cannot join
- Metastatic GIST, not fit for GA
About this study
Official title: Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series
Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Investigators hypothesized that laparoscopic resection of gastric GISTs even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.
Read the detailed description
Open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric GISTs has been proven but for tumors less than 2 cm. However, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. Our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. All these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.
- Conditions
- Gastric GIST, Submucosal Tumor of Stomach
- Being tested
- Laparoscopic resection
- Keywords
- Gastric GISTs, Submucosal tumours, Benign gastric lesions, Laparoscopic wedge resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resectionProcedure or surgery
all patients with suspected Gastric GIST undergoes laparoscopic resection. Tumour location decides the approach used for resection. Therefore, a variety of options such as local resections, wedge resections, transgastric resections, intragastric resection and partial gastrectomies were performed.
| Study group | Role | What they receive |
|---|---|---|
| gastric GIST | patients with suspected gastric GIST with size > 2cm are subjected for laparoscopic resection. Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of intraoperative tumour rupture
Any instances of tumour rupture during surgery is noted.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study startJan 2005
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric GISTStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhushan Chittawadagi, GEM Hospital & Research Center
- Investigators
- sandeep sabnis, DNB SGE, Study director, Gem Hospital & research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722056
- Sponsor's protocol ID
- Gem/2018/1157
- Status last verified
- Oct 2018
- First submitted
- 21 Oct 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential
Publications
Keung EZ, Raut CP. Management of Gastrointestinal Stromal Tumors. Surg Clin North Am. 2017 Apr;97(2):437-452. doi: 10.1016/j.suc.2016.12.001.
PubMed 28325196Park JJ. Long-Term Outcomes after Endoscopic Treatment of Gastric Gastrointestinal Stromal Tumor. Clin Endosc. 2016 May;49(3):232-4. doi: 10.5946/ce.2016.052. Epub 2016 May 19.
PubMed 27196737
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series
- ClinicalTrials.gov ID
- NCT03722056
- Acronym / sponsor ID
- Gem/2018/1157
- Conditions
- Gastric GIST, Submucosal Tumor of Stomach
- Keywords
- Gastric GISTs, Submucosal tumours, Benign gastric lesions, Laparoscopic wedge resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Oct 2018 (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.
Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Investigators hypothesized that laparoscopic resection of gastric GISTs even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.
Detailed description
Open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric GISTs has been proven but for tumors less than 2 cm. However, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. Our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. All these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric GIST | – | Procedure: Laparoscopic resectionpatients with suspected gastric GIST with size > 2cm are subjected for laparoscopic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with suspected Gastric GIST with size more than 2 cm
Key inclusion criteria (1 listed)
- Gastric GIST>2cm size
Key exclusion criteria (1 listed)
- Metastatic GIST, not fit for GA
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 |
|---|---|---|
| Laparoscopic resectionall patients with suspected Gastric GIST undergoes laparoscopic resection. Tumour location decides the approach used for resection. Therefore, a variety of options such as local resections, wedge resections, transgastric resections, intragastric resection and partial gastrectomies were performed. | Procedure or surgery | gastric GIST |
Primary outcome
rates of intraoperative tumour rupture
Time frame: intraoperative
Any instances of tumour rupture during surgery is noted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Results publication: PubMed 28325196Keung EZ, Raut CP. Management of Gastrointestinal Stromal Tumors. Surg Clin North Am. 2017 Apr;97(2):437-452. doi: 10.1016/j.suc.2016.12.001.
- Results publication: PubMed 27196737Park JJ. Long-Term Outcomes after Endoscopic Treatment of Gastric Gastrointestinal Stromal Tumor. Clin Endosc. 2016 May;49(3):232-4. doi: 10.5946/ce.2016.052. Epub 2016 May 19.
- Individual participant dataSharing planned: No. Data is confidential
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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.
sandeep sabnis, DNB SGE study director
Gem Hospital & research Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric GIST and Submucosal Tumor of Stomach, run by GEM Hospital & Research Center.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rates of intraoperative tumour rupture (time frame: intraoperative). 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 NCT03722056, which also lists 2 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 26 Oct 2018.