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

Primary Purpose

Gastrointestinal Stromal Tumor of Stomach

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic gastric gastrointestinal stromal tumors resection
Sponsored by
JIANG Zhi-Wei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor of Stomach focused on measuring Gastrointestinal stromal tumors, Robot, manual suture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinling Hospital, Medical School of Nanjing University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The robot group

Arm Description

Patients undergo robotic gastric gastrointestinal stromal tumors resection.

Outcomes

Primary Outcome Measures

Complications
Intraoperative and postoperative complications

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2017
Last Updated
July 31, 2017
Sponsor
JIANG Zhi-Wei
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1. Study Identification

Unique Protocol Identification Number
NCT03238820
Brief Title
Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
Official Title
Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2014 (Actual)
Primary Completion Date
August 5, 2016 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JIANG Zhi-Wei

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor of Stomach
Keywords
Gastrointestinal stromal tumors, Robot, manual suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group, open study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The robot group
Arm Type
Experimental
Arm Description
Patients undergo robotic gastric gastrointestinal stromal tumors resection.
Intervention Type
Procedure
Intervention Name(s)
Robotic gastric gastrointestinal stromal tumors resection
Intervention Description
Robotic gastric gastrointestinal stromal tumors resection
Primary Outcome Measure Information:
Title
Complications
Description
Intraoperative and postoperative complications
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Blood loss
Description
Blood loss
Time Frame
1 day
Title
Operative time
Description
Operative time
Time Frame
1 day
Title
Resection style
Description
The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.
Time Frame
1 day
Title
Postoperative length of stay
Description
Postoperative length of stay
Time Frame
1 month
Title
Inflammation level
Description
Inflammation level
Time Frame
1 month
Title
Nutritional status
Description
Nutritional status
Time Frame
6 months
Title
Body composition
Description
Body composition
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Wei JIANG, Ph.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian ZHAO, Ph.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Jinling Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The results and IPD might be considered to share in published articles.

Learn more about this trial

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

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