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

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Stromal Tumor of Stomach
• Intervention / Treatment: Procedure: Robotic gastric gastrointestinal stromal tumors 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital, Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The robot group; Patients undergo robotic gastric gastrointestinal stromal tumors resection.	Procedure: Robotic gastric gastrointestinal stromal tumors resection; Robotic gastric gastrointestinal stromal tumors resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Intraoperative and postoperative complications	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JIANG Zhi-Wei

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2014
• Primary Completion (Actual): August 5, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Robot; Gastrointestinal stromal tumors; manual suture
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Connective Tissue; Stomach Neoplasms; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: BE2015687GIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The results and IPD might be considered to share in published articles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No