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Completed

NCT Number: NCT03238820

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

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic gastric gastrointestinal stromal tumors resection

Procedure

Robotic gastric gastrointestinal stromal tumors resection

Primary outcomes

  1. Complications

    Time frame: 1 month

    Intraoperative and postoperative complications

Secondary outcomes

  1. Blood loss

    Time frame: 1 day

    Blood loss

  2. Operative time

    Time frame: 1 day

    Operative time

  3. Resection style

    Time frame: 1 day

    The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.

  4. Postoperative length of stay

    Time frame: 1 month

    Postoperative length of stay

  5. Inflammation level

    Time frame: 1 month

    Inflammation level

  6. Nutritional status

    Time frame: 6 months

    Nutritional status

  7. Body composition

    Time frame: 6 months

    Body composition

Sponsors and collaborators

Lead sponsor

JIANG Zhi-Wei

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 3, 2017
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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