Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

Gastric GIST Clinical Trial

Official title:

Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722056
• Other study ID #: Gem/2018/1157
• Status: Completed
• Start date: January 2005
• Est. completion date: July 2015

Study information

• Verified date: October 2018
• Source: GEM Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gastric GIST>2cm size

Exclusion Criteria:

• Metastatic GIST, not fit for GA

Related Conditions & MeSH terms

• Gastric GIST
• Gastrointestinal Stromal Tumors
• Stomach Neoplasms
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rates of intraoperative tumour rupture	Any instances of tumour rupture during surgery is noted.	intraoperative