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
About this trial
This is an interventional treatment trial for Gastric GIST
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)
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
NCT ID
NCT04751591
First Posted
January 30, 2021
Last Updated
November 29, 2021
Sponsor
Shanghai Zhongshan Hospital
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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Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
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