Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07405125

Safety of Robotic Surgery for GISTs at Special Anatomic Sites

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-02-12

182

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a prospective, multicenter, single-arm, phase II clinical trial. It plans to enroll 182 patients with localized gastric gastrointestinal stromal tumors (GISTs) at special anatomic sites. Eligible patients who meet the inclusion/exclusion criteria and provide written informed consent will undergo robotic radical surgery. Postoperative treatment will be determined jointly by the clinicians and patients based on actual clinical practice.

CONDITIONS

Official Title

Safety of Robotic Surgery for GISTs at Special Anatomic Sites

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, regardless of sex.
  • Diagnosis of GIST at a special anatomic site confirmed by endoscopy, CT, or MRI.
  • Tumor size between 2 cm and 5 cm based on preoperative imaging.
  • No prior neoadjuvant therapy such as imatinib.
  • Expected survival of at least 6 months.
  • Assessed as suitable for robotic surgery.
  • No distant metastasis or invasion into adjacent organs.
  • ECOG Performance Status score of 0 or 1.
  • ASA Physical Status classification between I and III.
  • Provided written informed consent after understanding study information.
Not Eligible

You will not qualify if you...

  • Previous upper abdominal surgery except laparoscopic cholecystectomy.
  • History of gastrectomy, endoscopic mucosal resection, or submucosal dissection.
  • Prior neoadjuvant therapy such as imatinib.
  • Other active cancers within the past 5 years or currently, except certain cured localized tumors.
  • Need for surgery for other diseases at the same time.
  • Emergency surgery due to tumor complications like bleeding or obstruction.
  • Thrombotic events like stroke or deep vein thrombosis within 6 months prior.
  • Recent myocardial infarction or poorly controlled arrhythmia.
  • Severe heart failure or reduced heart pumping function.
  • Ventilatory dysfunction with FEV1 below 50% predicted.
  • Symptomatic pleural or abdominal fluid requiring treatment.
  • HIV infection.
  • Active pulmonary tuberculosis.
  • History or presence of severe lung diseases affecting detection or treatment.
  • Active infections needing systemic treatment within 14 days before surgery (except prophylactic antibiotics).
  • Participation in other surgical clinical trials.
  • History of substance abuse.
  • Likely non-compliance with treatment or incomplete data.
  • Pregnant or lactating women.
  • Any other condition increasing risk or judged unsuitable by investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

Q

Qiang Zhang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Safety of Robotic Surgery for GISTs at Special Anatomic Sites | DecenTrialz