Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

• ClinicalTrials.gov Identifier: NCT03722056
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: October 26, 2018
• Sponsor: GEM Hospital & Research Center
• Information provided by (Responsible Party): Bhushan Chittawadagi, GEM Hospital & Research Center

Tracking Information

• First Submitted Date: October 21, 2018
• First Posted Date: October 26, 2018
• Last Update Posted Date: October 26, 2018
• Actual Study Start Date: January 2005
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2018)

rates of intraoperative tumour rupture [ Time Frame: intraoperative ]

Any instances of tumour rupture during surgery is noted.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach
• Official Title: Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: all patients with suspected Gastric GIST with size more than 2 cm

Condition

• Gastric GIST
• Submucosal Tumor of Stomach

Intervention

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.

Study Groups/Cohorts

gastric GIST

patients with suspected gastric GIST with size > 2cm are subjected for laparoscopic resection.

Intervention: Procedure: Laparoscopic resection

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.
• Park 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2018): 42
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Gastric GIST>2cm size

Exclusion Criteria:

• Metastatic GIST, not fit for GA

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03722056
• Other Study ID Numbers: Gem/2018/1157
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Data is confidential

• Current Responsible Party: Bhushan Chittawadagi, GEM Hospital & Research Center
• Original Responsible Party: Same as current
• Current Study Sponsor: GEM Hospital & Research Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: sandeep sabnis, DNB SGE; Gem Hospital & research Centre

• PRS Account: GEM Hospital & Research Center
• Verification Date: October 2018