Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

NCT ID: NCT03722056

Last Updated: 2018-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Gastric GIST Submucosal Tumor of Stomach

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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gastric GIST

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

Laparoscopic resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gastric GIST\>2cm size

Exclusion Criteria

* Metastatic GIST, not fit for GA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEM Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Bhushan Chittawadagi

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sandeep sabnis, DNB SGE

Role: STUDY_DIRECTOR

Gem Hospital & research Centre

References

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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.

Reference Type RESULT
PMID: 28325196 (View on PubMed)

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.

Reference Type RESULT
PMID: 27196737 (View on PubMed)

Other Identifiers

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Gem/2018/1157

Identifier Type: -

Identifier Source: org_study_id

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