NCT05197933

Brief Summary

The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

5 years

First QC Date

September 7, 2021

Last Update Submit

January 14, 2022

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal TumorsUnfavorable Anatomic Site of StomachLaparoscopic Resection

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival rate (DFS)

    The number of patients with DFS \> 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.

    until the date of first documented progression, assessed up to 3 years

Secondary Outcomes (6)

  • Success rate of laparoscopic surgery

    postoperative 15 days

  • Rate of intraoperative complication

    intraoperative time

  • Rate of Postoperative complication

    postoperative 30 days, or the discharge day if hospitalization>30 days

  • 3-year overall survival rate (OS)

    until the date of first documented progression, assessed up to 3 years

  • Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food）

    postoperative 30 days, or the discharge day if hospitalization>30 days

  • +1 more secondary outcomes

Study Arms (1)

Laparoscopic resection

EXPERIMENTAL

laparoscopic resection for GIST at unfavorable anatomic sites of stomach

Procedure: Laparoscopic resection

Interventions

Laparoscopic resectionPROCEDURE

Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted

Laparoscopic resection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from over 18 to under 75 years;
  • Gastrointestinal stromal tumor at unfavorable anatomic sites of stomach preoperatively confirmed by endoscopy, ultrasound endoscopy, CT or MRI;
  • Diameter of tumor size is ≥2cm and ≤5cm confirmed by contrast CT or MRI;
  • Patients whose tumor is resectable by laparoscopic technique at preoperative assessment;
  • No evidence of distant metastasis and tumor invading nearby organs at preoperative assessment;
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
  • ASA (American Society of Anesthesiology) score I, II, or III;
  • Written informed consent.

You may not qualify if:

  • Women during pregnancy or breast-feeding;
  • Severe mental disorder;
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy);
  • History of other malignant disease within the past five years;
  • History of previous neoadjuvant imatinib therapy;
  • History of unstable angina or myocardial infarction within the past six months;
  • History of cerebrovascular accident within the past six months;
  • History of continuous systematic administration of corticosteroids within the past month;
  • Requirement of simultaneous surgery for other disease;
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastrointestinal stromal tumor;
  • FEV1\<50% of predicted value;
  • Patients with GIST locates at favorable anatomic sites detected by contrast CT, MRI or ultrasound endoscopy at preoperative assessment;
  • Patients with GIST diameter\<2cm or\>5cm detected by contrast CT or MRI;
  • Presence of distant metastasis or tumor invading nearby organs at preoperative assessment.
  • Withdrawal Criteria:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Hui Cao, Professor

    RenJi Hospital

    STUDY CHAIR

Central Study Contacts

Hui Cao, Professor

CONTACT

13918141425caohuishcn@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Blinding Method: Open Label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicenter, open-label, single-arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2021

First Posted

January 20, 2022

Study Start

October 1, 2020

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

CN(1)