Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751591
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-01-30
Brief Title:
Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None