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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03238820
Enrollment
50
Registered
2017-08-03
Start date
2014-01-10
Completion date
2017-06-01
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumor of Stomach

Keywords

Gastrointestinal stromal tumors, Robot, manual suture

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.

Interventions

PROCEDURERobotic gastric gastrointestinal stromal tumors resection

Robotic gastric gastrointestinal stromal tumors resection

Sponsors

JIANG Zhi-Wei
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a single group, open study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complications1 monthIntraoperative and postoperative complications

Secondary

MeasureTime frameDescription
Operative time1 dayOperative time
Resection style1 dayThe wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.
Postoperative length of stay1 monthPostoperative length of stay
Blood loss1 dayBlood loss
Nutritional status6 monthsNutritional status
Body composition6 monthsBody composition
Inflammation level1 monthInflammation level

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026