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

NCT03238820 | Completed

• 1 other identifier: BE2015687GIST
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Conditions

Gastrointestinal Stromal Tumor of Stomach

Keywords

Gastrointestinal stromal tumors; Robot; manual suture

Outcome Measures

Primary Outcomes (1)

• Complications

  Intraoperative and postoperative complications

  1 month

Secondary Outcomes (7)

• Blood loss

  1 day

• Operative time

  1 day

• Resection style

  1 day

• Postoperative length of stay

  1 month

• Inflammation level

  1 month

Study Arms (1)

The robot group

EXPERIMENTAL

Patients undergo robotic gastric gastrointestinal stromal tumors resection.

Procedure: Robotic gastric gastrointestinal stromal tumors resection

Interventions

Robotic gastric gastrointestinal stromal tumors resection PROCEDURE

Robotic gastric gastrointestinal stromal tumors resection

The robot group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JIANG Zhi-Wei: lead

Study Sites (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Zhi-Wei JIANG, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  PRINCIPAL INVESTIGATOR

• Jian ZHAO, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Research Institute of General Surgery

Model Details: This is a single group, open study.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 3, 2017
• Study Start: January 10, 2014
• Primary Completion: August 5, 2016
• Study Completion: June 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-07

Locations

CN (1)