Safety of Robotic Surgery for GISTs at Special Anatomic Sites

NCT07405125 | Recruiting

• 2 other identifiers: JROS-0022025-SR-793
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastrointenstinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival rate (3-year DFS)

  The proportion of patients who develop tumor recurrence among all patients who underwent surgery is calculated at the 3-year mark following the date of surgery.

  Patients were followed for 3 years after undergoing robotic surgery.

Study Arms (1)

Robotic group

EXPERIMENTAL

Procedure: Robotic Surgery

Interventions

Robotic Surgery PROCEDURE

To perform robotic radical surgery with the aim of achieving R0 resection.

Robotic group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years, regardless of sex.
• Diagnosis of GIST located at a special anatomic site confirmed preoperatively by endoscopy/endoscopic ultrasound, CT, or MRI.
• Preoperative imaging suggests a tumor diameter between 2 cm and 5 cm.
• No prior neoadjuvant therapy (e.g., imatinib) administered.
• Expected survival period ≥ 6 months.
• Preoperative assessment indicates feasibility for robotic surgery.
• Preoperative examinations show no evidence of distant metastasis or direct invasion into adjacent organs.
• Preoperative ECOG Performance Status score of 0 or 1.
• Preoperative ASA Physical Status classification of I to III.
• The subject has read and fully understood the patient information sheet and provided written informed consent.

You may not qualify if:

• History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
• History of previous gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
• Previous administration of neoadjuvant therapy (e.g., imatinib).
• Presence of other active malignancies within the past 5 years or concurrently. (Note: Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, Stage I lung cancer, or Stage I colorectal cancer, may be enrolled.)
• Requirement for concurrent surgery for other diseases.
• Emergency surgery performed due to tumor-related complications (bleeding, obstruction, or perforation).
• Arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (excluding thrombosis related to prior chemotherapy venous catheters deemed resolved by the investigator), and pulmonary embolism.
• Myocardial infarction within 6 months prior to surgery, or poorly controlled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females, calculated using Fridericia's formula).
• Cardiac insufficiency classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \<50% on cardiac ultrasound.
• Ventilatory dysfunction: FEV1 \<50% of predicted value.
• Clinically symptomatic pleural or abdominal effusion requiring clinical intervention.
• Human Immunodeficiency Virus (HIV) infection.
• Active pulmonary tuberculosis.
• History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• Any active infection requiring systemic anti-infective therapy within 14 days prior to surgery; except for prophylactic antibiotic therapy (e.g., for urinary tract infection or chronic obstructive pulmonary disease).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

• 1.Open and minimally invasive surgery for gastrointestinal stromal tumours a systematic review and network meta-analysis protocol. BMJ Open. 2022;12(2):e050414. 2.Robotic Function-Preserving Resection of Gastric Gastrointestinal Stromal Tumor. J Surg Res. 2023 Oct:290:164-170. 3.Application of Intragastric Single-Incision Laparoscopy Surgery in the Management of Gastroesophageal Junction Gastrointestinal Stromal Tumors. J Vis Exp. 2025 Jun 17:(220) 4.Robotic excision of gastric and duodenal gastrointestinal stromal tumor. Updates Surg. 2022 Aug;74(4):1483-1484. 5. Laparoscopic and robot-assisted procedures in patients with gastrointestinal stromal tumors (GIST) of stomach. Khirurgiia (Mosk). 2020:(1):5-13. 6.Robotic limited local resection of duodenal juxta-ampullary neoplasms. Int J Med Robot. 2021 Apr;17(2):e2192. 7.Robotic duodenal (D3) resection with Roux-en-Y duodenojejunostomy reconstruction for large GIST tumor Step by step with video. Surg Oncol. 2021 Mar:36:130. 8.Is minimally invasive surgery for large gastric GIST actually safe? A comparative analysis of short- and long-term outcomes. Surg Endosc. 2022 Sep;36(9):6975-6983 9.Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres) study protocol and statistical analysis plan for a German multicentre single-blind surgical registry-based randomised controlled trial. BMJ Open. 2021 Nov 29;11(11):e056191 10.Robot-assisted laparoscopic combined with endoscopic partial gastrectomy (RALE-PG) for the treatment of gastric gastrointestinal stromal tumors in challenging anatomical locations single-center experience. Front Surg. 2024 May 23:11:1391387. 11.Oncologic outcomes and survival of modern surgical approaches for gastric gastrointestinal stromal tumor (GIST). Surg Endosc. 2024 Nov;38(11):6854-6864. 12.Open versus laparoscopic versus robotic gastric gastrointestinal stromal tumour resections A multicentre cohort study. Int J Med Robot. 2021 Apr;17(2):e2198.

  BACKGROUND

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Central Study Contacts

Qiang Zhang, Ph.D

CONTACT

+86 18851727696; zhqsq@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting information will be available starting in January 2029 for two years.
• Access Criteria: Interested investigators may request access by contacting zhqsq@qq.com via email. The information available includes detailed study protocol, primary outcome data, as well as analysis results and procedures.

Locations

CN (1)