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Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor

Primary Purpose

Gastric GIST

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic resection
Laparoscopic partial gastrectomy
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric GIST

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination
  • The maximum diameter of the tumor is > 2cm and ≤ 5cm
  • No history of upper abdominal surgery (except for laparoscopic cholecystectomy)
  • No history of neoadjuvant therapy or targeted therapy
  • Preoperative performance status (ECOG,Eastern Cooperative Oncology Group) of 0 or 1
  • Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
  • Sufficient organ functions
  • Written informed consent

Exclusion Criteria:

  • Gastric GISTs with completely extra-luminal growth pattern
  • Metastases found in preopreative examinations
  • History of simultaneous malignancies or heterochronous malignancies within 5 years
  • Women during pregnancy or breast-feeding
  • Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery
  • Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
  • Severe mental disease
  • Severe respiratory disease
  • Severe hepatic and renal dysfunction
  • Unstable angina pectoris or history of myocardial infarction within 6 months
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • Patients with other diseases who can be surgically intervened at the same time
  • Continuous systemic steroid therapy within 1 month (except for topical use)
  • Patients are participating or have participated in another clinical trial (within 6 months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Endoscopic resection

    Laparoscopic partial gastrectomy

    Arm Description

    The endoscopist will perform endoscopic resection for patients enrolled in this group.

    The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.

    Outcomes

    Primary Outcome Measures

    Early operative morbidity rate
    The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
    Early operative mortality rate
    The early operative mortality is defined as deaths observed within 30 days following surgery.

    Secondary Outcome Measures

    Operation time
    Operation time is documented as a composite outcome measure.
    Time to first ambulation
    Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time to first flatus
    Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time to first liquid diet
    Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time to first soft diet
    Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
    Postoperative hospital stay
    The length of postoperative hospital stay will be recorded.
    En bloc resection rate
    The rate of en bloc resection in all cases will be recorded.

    Full Information

    First Posted
    January 30, 2021
    Last Updated
    November 29, 2021
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04751591
    Brief Title
    Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
    Official Title
    Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Endoscopic Resection And Laparoscopic Partial Gastrectomy In Patients With 2-5cm Gastric Gastrointestinal Stromal Tumor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.
    Detailed Description
    Gastrointestinal stromal tumors (GIST) originate from interstitial cells of Cajal (ICC) and are the most common tumors derived from mesenchymal tissues of the digestive tract. GISTs can occur in any part of the digestive tract, among which gastric stromal tumors are the most common, accounting for about 60%. The incidence of GIST has been increasing in recent years, partly due to the gradual popularity of gastrointestinal endoscopy. Many early GISTs with smaller tumors have also received early diagnosis and treatment intervention. Due to the potential malignancy of GISTs, complete resection of the tumor is the first and only radical treatment option currently. Many studies have shown that laparoscopy is safe and effective approach in the treatment of gastric stromal tumors. In principle, as long as the tumor can be completely resected (neither residue macro nor microscopic) with intact tumor capsule and without tumor rupture, laparoscopic surgery is definite an option. Studies showed both short-term and long-term results of laparoscopic surgery were comparable to conventional open surgeries. On the other hand, endoscopic resection showed promising results in recent years. Endoscopic submucosal dissection endoscopic full-thickness resection are both reported with promising results in terms of safety and short-term efficacy. Though endoscopic resection has been suggested as one of the treatment options for gastric GISTs, No randomized controlled trial for endoscopic resection versus laparoscopic partial gastrectomy exists at this moment. This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric GISTs. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric GISTs. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric GIST

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endoscopic resection
    Arm Type
    Experimental
    Arm Description
    The endoscopist will perform endoscopic resection for patients enrolled in this group.
    Arm Title
    Laparoscopic partial gastrectomy
    Arm Type
    Other
    Arm Description
    The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic resection
    Intervention Description
    Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic partial gastrectomy
    Intervention Description
    Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
    Primary Outcome Measure Information:
    Title
    Early operative morbidity rate
    Description
    The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
    Time Frame
    30 days
    Title
    Early operative mortality rate
    Description
    The early operative mortality is defined as deaths observed within 30 days following surgery.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Operation time
    Description
    Operation time is documented as a composite outcome measure.
    Time Frame
    intraoperative
    Title
    Time to first ambulation
    Description
    Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time Frame
    30 days
    Title
    Time to first flatus
    Description
    Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time Frame
    30 days
    Title
    Time to first liquid diet
    Description
    Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time Frame
    30 days
    Title
    Time to first soft diet
    Description
    Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
    Time Frame
    30 days
    Title
    Postoperative hospital stay
    Description
    The length of postoperative hospital stay will be recorded.
    Time Frame
    30 days
    Title
    En bloc resection rate
    Description
    The rate of en bloc resection in all cases will be recorded.
    Time Frame
    0, day of endoscopic surgery or laparoscopic surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination The maximum diameter of the tumor is > 2cm and ≤ 5cm No history of upper abdominal surgery (except for laparoscopic cholecystectomy) No history of neoadjuvant therapy or targeted therapy Preoperative performance status (ECOG,Eastern Cooperative Oncology Group) of 0 or 1 Preoperative ASA (American Society of Anesthesiologists) scoring: I-III Sufficient organ functions Written informed consent Exclusion Criteria: Gastric GISTs with completely extra-luminal growth pattern Metastases found in preopreative examinations History of simultaneous malignancies or heterochronous malignancies within 5 years Women during pregnancy or breast-feeding Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated Severe mental disease Severe respiratory disease Severe hepatic and renal dysfunction Unstable angina pectoris or history of myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months Patients with other diseases who can be surgically intervened at the same time Continuous systemic steroid therapy within 1 month (except for topical use) Patients are participating or have participated in another clinical trial (within 6 months)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tianyin Chen
    Phone
    +862164041990
    Email
    chen_tianyin@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pinghong Zhou
    Organizational Affiliation
    Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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