Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

Completed

• Conditions: Gastric GIST; Submucosal Tumor of Stomach
• Interventions: Procedure: Laparoscopic resection

• Registration Number: NCT03722056
• Lead Sponsor: GEM Hospital & Research Center

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-10
• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-25
• Study First Posted: 2018-10-26
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Gastric GIST>2cm size

Exclusion Criteria

• Metastatic GIST, not fit for GA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastric GIST	Laparoscopic resection	patients with suspected gastric GIST with size \> 2cm are subjected for laparoscopic resection.

Primary Outcome Measures

Name	Time	Method
rates of intraoperative tumour rupture	intraoperative	Any instances of tumour rupture during surgery is noted.