Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study

Not Applicable

Completed

• Conditions: Gastrointestinal Stromal Tumor of Stomach
• Interventions: Procedure: Robotic gastric gastrointestinal stromal tumors resection

• Registration Number: NCT03238820
• Lead Sponsor: JIANG Zhi-Wei

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 Timeline

• Study Start: 2014-01-10
• Primary Completion: 2016-08-05
• Study Completion: 2017-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
2. Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
3. American Society of Anesthesiologists (ASA) physical status I-III.
4. Participants can follow the visit plan.

Exclusion Criteria

1. Patients certified by a doctor that doesn't fit to participate in this study.
2. 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).
3. Patients with gastrointestinal stromal tumor with distant metastasis.
4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
5. Patients with gastrointestinal operations and complicated abdominal operations.
6. 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).
7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
8. Patients participated other subjects 3 months before this subject.
9. Sponsors or researchers directly involved in the testing or their family members.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The robot group	Robotic gastric gastrointestinal stromal tumors resection	Patients undergo robotic gastric gastrointestinal stromal tumors resection.

Primary Outcome Measures

Name	Time	Method
Complications	1 month	Intraoperative and postoperative complications

Secondary Outcome Measures

Name	Time	Method
Blood loss	1 day	Blood loss
Operative time	1 day	Operative time
Resection style	1 day	The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.
Postoperative length of stay	1 month	Postoperative length of stay
Inflammation level	1 month	Inflammation level
Nutritional status	6 months	Nutritional status
Body composition	6 months	Body composition

Trial Locations

Locations (1)

Jinling Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China