NCT03722056

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

10.5 years

First QC Date

October 21, 2018

Last Update Submit

October 25, 2018

Conditions

Gastric GISTSubmucosal Tumor of Stomach

Keywords

Gastric GISTsSubmucosal tumoursBenign gastric lesionsLaparoscopic wedge resection

Outcome Measures

Primary Outcomes (1)

  • rates of intraoperative tumour rupture

    Any instances of tumour rupture during surgery is noted.

    intraoperative

Study Arms (1)

gastric GIST

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

Procedure: Laparoscopic resection

Interventions

Laparoscopic resectionPROCEDURE

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.

gastric GIST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with suspected Gastric GIST with size more than 2 cm

You may qualify if:

  • Gastric GIST\>2cm size

You may not qualify if:

  • Metastatic GIST, not fit for GA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 28325196RESULT

  • 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.

    PMID: 27196737RESULT

Study Officials

  • sandeep sabnis, DNB SGE

    Gem Hospital & research Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 21, 2018

First Posted

October 26, 2018

Study Start

January 1, 2005

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Data is confidential