Trial record 208 of 350 for:
Gastrointestinal Stromal Tumors
Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach
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| ClinicalTrials.gov Identifier: NCT03722056 |
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Recruitment Status :
Completed
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
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Sponsor:
GEM Hospital & Research Center
Information provided by (Responsible Party):
Bhushan Chittawadagi, GEM Hospital & Research Center
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Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Gastric GIST Submucosal Tumor of Stomach | Procedure: Laparoscopic resection |
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 Type : | Observational |
| Actual Enrollment : | 42 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series |
| Actual Study Start Date : | January 2005 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Gastrointestinal stromal tumor
MedlinePlus related topics:
Stomach Cancer
| Group/Cohort | Intervention/treatment |
|---|---|
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gastric GIST
patients with suspected gastric GIST with size > 2cm are subjected for laparoscopic resection.
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Procedure: Laparoscopic resection
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. |
Primary Outcome Measures :
- rates of intraoperative tumour rupture [ Time Frame: intraoperative ]Any instances of tumour rupture during surgery is noted.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
all patients with suspected Gastric GIST with size more than 2 cm
Criteria
Inclusion Criteria:
- Gastric GIST>2cm size
Exclusion Criteria:
- Metastatic GIST, not fit for GA
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722056
Sponsors and Collaborators
GEM Hospital & Research Center
Investigators
| Study Director: | sandeep sabnis, DNB SGE | Gem Hospital & research Centre |
Publications of Results:
| Responsible Party: | Bhushan Chittawadagi, principal investigator, GEM Hospital & Research Center |
| ClinicalTrials.gov Identifier: | NCT03722056 |
| Other Study ID Numbers: |
Gem/2018/1157 |
| First Posted: | October 26, 2018 Key Record Dates |
| Last Update Posted: | October 26, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Data is confidential |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bhushan Chittawadagi, GEM Hospital & Research Center:
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Gastric GISTs Submucosal tumours Benign gastric lesions Laparoscopic wedge resection |
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors Stomach Neoplasms Neoplasms Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms by Site Stomach Diseases |