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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-10

Study Completion Date

2017-06-01

Brief Summary

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Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

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Detailed Description

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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.

Conditions

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Gastrointestinal Stromal Tumor of Stomach

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single group, open study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The robot group

Patients undergo robotic gastric gastrointestinal stromal tumors resection.

Group Type EXPERIMENTAL

Robotic gastric gastrointestinal stromal tumors resection

Intervention Type PROCEDURE

Robotic gastric gastrointestinal stromal tumors resection

Interventions

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Robotic gastric gastrointestinal stromal tumors resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No