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

Gastrointestinal Stromal Tumor of Stomach Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238820
• Other study ID #: BE2015687GIST
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: July 31, 2017
• Start date: January 10, 2014
• Est. completion date: June 1, 2017

Study information

• Verified date: July 2017
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2017
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor of Stomach
• Gastrointestinal Stromal Tumors
• Stomach Neoplasms

Intervention

Procedure:
• Robotic gastric gastrointestinal stromal tumors resection
Robotic gastric gastrointestinal stromal tumors resection

Locations

Country	Name	City	State
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
JIANG Zhi-Wei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Intraoperative and postoperative complications	1 month
Secondary	Blood loss	Blood loss	1 day
Secondary	Operative time	Operative time	1 day
Secondary	Resection style	The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.	1 day
Secondary	Postoperative length of stay	Postoperative length of stay	1 month
Secondary	Inflammation level	Inflammation level	1 month
Secondary	Nutritional status	Nutritional status	6 months
Secondary	Body composition	Body composition	6 months