Clinical trial NCT03238820: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Stromal Tumor of Stomach
Keywords: Gastrointestinal stromal tumors
Robot
manual suture
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group, open study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complications
timeFrame: 1 month
Secondary outcomes:
measure: Blood loss
timeFrame: 1 day
measure: Operative time
timeFrame: 1 day
measure: Resection style
timeFrame: 1 day
measure: Postoperative length of stay
timeFrame: 1 month
measure: Inflammation level
timeFrame: 1 month
measure: Nutritional status
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Zhi-Wei JIANG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jian ZHAO, Ph.D.
role: STUDY_DIRECTOR
References: