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NCT Number: NCT07237126

Single-port Robotic Radical Gastrectomy for Gastric Cancer

This study is a single-center, phase 2a exploratory clinical study based on IDEAL framework. The intraoperative and postoperative complications were analyzed to evaluate the safety, feasibility and clinical efficacy of single-port robot-assisted gastric tumor resection.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathological indices of Single-port robot-assisted radical gastrectomy for gastric cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) Age: 18-75 years; (2) Histologically confirmed gastric adenocarcinoma by endoscopic biopsy; (3) Preoperatively staged as either endoscopically unresectable T1, or cT2-4a with or without nodal involvement (N-/+), and no distant metastasis (M0), according to the 7th edition of the AJCC Cancer Staging Manual; (4) Eligible for potentially curative surgical resection; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) American Society of Anesthesiologists (ASA) physical status classification of I-III; (7) Provision of written informed consent.

Exclusion criteria

  • (1) Pregnant or lactating women; (2) Severe psychiatric disorder; (3) History of prior upper abdominal surgery; (4) Previous gastrectomy, endoscopic submucosal dissection (ESD), or endoscopic mucosal resection (EMR); (5) Preoperative imaging showing regional lymphadenopathy with lymph node(s) larger than 3 cm in diameter; (6) History of another primary malignancy within the past 5 years; (7) Prior neoadjuvant chemotherapy or radiotherapy; (8) History of cerebrovascular or cardiovascular event (e.g., stroke or myocardial infarction) within the past 6 months; (9) Systemic corticosteroid use for more than one month within the past month; (10) Requirement for concomitant surgery for other conditions; (11) Need for emergency surgery due to gastric cancer-related complications (e.g., bleeding, obstruction, or perforation); (12) Participation in another interventional clinical trial previously; (13) Active severe infectious disease; (14) Severe systemic disease.

Treatment and study plan

Single-port Robotic Radical Gastrectomy for Gastric Cancer

Procedure

Single-port Robotic Radical Gastrectomy for Gastric Cancer

Primary outcomes

  1. Intraoperative adverse events and 30-day postoperative complications

    Time frame: Intraoperative and postoperative 30 days

    Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days.

  2. Conversion rate

    Time frame: Intraoperative

    Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .

Secondary outcomes

  1. Length of incision

    Time frame: Intraoperative

    The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure.

  2. Intraoperative Blood Loss

    Time frame: Intraoperative

    The estimated volume of blood lost during surgery (in milliliters), calculated based on suction collection volume and the weight of used gauze sponges, using standard conversion methods.

  3. Operative Time

    Time frame: Intraoperative

    The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence.

  4. Postoperative Length of Hospital Stay

    Time frame: 7 days after surgery

    The number of days between the day of surgery (postoperative day 0) and the day of hospital discharge, inclusive of the discharge day if applicable per institutional protocol.

  5. Number of Lymph Nodes Harvested

    Time frame: 7 days after surgery

    The total count of lymph nodes removed during the lymphadenectomy and confirmed by pathological examination.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Registry information

Official study title

Efficacy and Safety Assessment of Single-port Robotic Radical Gastrectomy for Gastric Cancer: a Phase 2a Trial Based on the IDEAL Framework

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

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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