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

NCT04751591 | Unknown

• 1 other identifier: SK2020-032
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric GIST

Outcome Measures

Primary Outcomes (2)

• Early operative morbidity rate

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

  30 days

• Early operative mortality rate

  The early operative mortality is defined as deaths observed within 30 days following surgery.

  30 days

Secondary Outcomes (7)

• Operation time

  intraoperative

• Time to first ambulation

  30 days

• Time to first flatus

  30 days

• Time to first liquid diet

  30 days

• Time to first soft diet

  30 days

Study Arms (2)

Endoscopic resection

EXPERIMENTAL

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

Procedure: Endoscopic resection

Laparoscopic partial gastrectomy

OTHER

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

Procedure: Laparoscopic partial gastrectomy

Interventions

Endoscopic resection PROCEDURE

Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs

Endoscopic resection

Laparoscopic partial gastrectomy PROCEDURE

Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs

Laparoscopic partial gastrectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (18)

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MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Pinghong Zhou

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianyin Chen

CONTACT

+862164041990; chen_tianyin@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 12, 2021
• Study Start: December 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share