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

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ClinicalTrials.gov Identifier: NCT04751591
Recruitment Status : Not yet recruiting
First Posted : February 12, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric GIST Procedure: Endoscopic resection Procedure: Laparoscopic partial gastrectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024


Arm Intervention/treatment
Experimental: Endoscopic resection
The endoscopist will perform endoscopic resection for patients enrolled in this group.
Procedure: Endoscopic resection
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs

Laparoscopic partial gastrectomy
The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
Procedure: Laparoscopic partial gastrectomy
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs




Primary Outcome Measures :
  1. Early operative morbidity rate [ Time Frame: 30 days ]
    The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.

  2. Early operative mortality rate [ Time Frame: 30 days ]
    The early operative mortality is defined as deaths observed within 30 days following surgery.


Secondary Outcome Measures :
  1. Operation time [ Time Frame: intraoperative ]
    Operation time is documented as a composite outcome measure.

  2. Time to first ambulation [ Time Frame: 30 days ]
    Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.

  3. Time to first flatus [ Time Frame: 30 days ]
    Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.

  4. Time to first liquid diet [ Time Frame: 30 days ]
    Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.

  5. Time to first soft diet [ Time Frame: 30 days ]
    Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.

  6. Postoperative hospital stay [ Time Frame: 30 days ]
    The length of postoperative hospital stay will be recorded.

  7. En bloc resection rate [ Time Frame: 0, day of endoscopic surgery or laparoscopic surgery ]
    The rate of en bloc resection in all cases will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751591


Contacts
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Contact: Tianyin Chen +862164041990 chen_tianyin@126.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Pinghong Zhou Fudan University
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04751591    
Other Study ID Numbers: SK2020-032
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases