Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Complications
Study Overview
Brief Summary
Patients with gastric gastrointestinal stromal tumors will receive robotic resection.
Detailed Description
Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
- •Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Participants can follow the visit plan.
Exclusion Criteria
- •Patients certified by a doctor that doesn't fit to participate in this study.
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
- •Patients with gastrointestinal stromal tumor with distant metastasis.
- •Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- •Patients with gastrointestinal operations and complicated abdominal operations.
- •Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, Subjective Global Assessment (SGA) classification C, body mass index <18, Hb<70g/L).
- •Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
- •Patients participated other subjects 3 months before this subject.
- •Sponsors or researchers directly involved in the testing or their family members.
Arms & Interventions
The robot group
Patients undergo robotic gastric gastrointestinal stromal tumors resection.
Intervention: Robotic gastric gastrointestinal stromal tumors resection (Procedure)
Outcomes
Primary Outcomes
Complications
Time Frame: 1 month
Intraoperative and postoperative complications
Secondary Outcomes
- Nutritional status(6 months)
- Blood loss(1 day)
- Operative time(1 day)
- Resection style(1 day)
- Postoperative length of stay(1 month)
- Inflammation level(1 month)
- Body composition(6 months)
Investigators
JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Jinling Hospital, China