NCT07828899

Brief Summary

This multicenter randomized non-inferiority trial evaluates single-port versus multi-port robotic-assisted radical distal gastrectomy in patients with gastric cancer. A prespecified prospective substudy will assess early postoperative pain, abdominal wall trauma, and early recovery between the two surgical approaches.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 4, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 4, 2026

Last Update Submit

September 14, 2026

Conditions

STOMACH NEOPLASMRobotic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach

    Technical success is defined as completion of the protocol-specified gastrectomy, lymph node dissection, and gastrointestinal reconstruction using the robotic surgical approach assigned at randomization. In the single-port group, technical success requires completion using the single-port robotic system without conversion to multi-port robotic surgery, conventional laparoscopic surgery, or open surgery, and without any unplanned additional port beyond those permitted by the protocol. In the multi-port group, technical success requires completion using the multi-port robotic system without conversion to conventional laparoscopic surgery or open surgery. Failure to complete the assigned robotic procedure because of participant-related, operative, or device-related reasons will be classified as technical failure. The prespecified noninferiority margin is -10 percentage points.

    At the end of surgery

Secondary Outcomes (28)

  • Total Operative Time

    Intraoperative

  • Robotic Docking Time

    Intraoperative

  • Robotic Console Time

    Intraoperative

  • Intraoperative Blood Loss

    Intraoperative

  • Percentage of Participants With Intraoperative Complications

    Intraoperative

  • +23 more secondary outcomes

Study Arms (2)

Single-Port Robotic Gastrectomy Group

EXPERIMENTAL

Participants randomized to this group will undergo single-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol

Procedure: Single-Port Robot-Assisted Radical Distal Gastrectomy

Multi-Port Robotic Gastrectomy Group

ACTIVE COMPARATOR

Participants randomized to this group will undergo conventional multi-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol

Procedure: Multi-Port Robot-Assisted Radical Distal Gastrectomy

Interventions

Single-Port Robot-Assisted Radical Distal GastrectomyPROCEDURE

Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a single-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.

Single-Port Robotic Gastrectomy Group
Multi-Port Robot-Assisted Radical Distal GastrectomyPROCEDURE

Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a multi-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.

Multi-Port Robotic Gastrectomy Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years, irrespective of sex.
  • Histologically confirmed primary gastric adenocarcinoma based on endoscopic biopsy.
  • The primary tumor is located in the middle or distal third of the stomach, or at another site considered amenable to radical distal gastrectomy. Preoperative evaluation indicates that robot-assisted radical distal gastrectomy is technically feasible and that an R0 resection is anticipated. Patients who have received standard neoadjuvant therapy may also be eligible if reassessment confirms fulfillment of the above surgical criteria.
  • Clinical stage cT1-3N0-1M0 according to the 8th edition of the AJCC TNM staging system for gastric cancer, as assessed by gastroscopy and contrast-enhanced computed tomography of the chest, abdomen, and pelvis, with endoscopic ultrasonography, abdominal magnetic resonance imaging, or diagnostic laparoscopy performed when clinically indicated. Preoperative assessment should indicate that R0 resection can be achieved by distal gastrectomy, with no evidence of adjacent organ invasion or distant metastasis.
  • No history of other malignancies within the preceding 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with a similarly negligible risk of recurrence.
  • American Society of Anesthesiologists (ASA) physical status class I-III.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
  • Adequate major organ function, with preoperative assessment confirming fitness for general anesthesia and robot-assisted radical distal gastrectomy.
  • Subjects voluntarily participate in the study, fully understand the trial protocol and provide written informed consent.

You may not qualify if:

  • Body mass index (BMI) \>35 kg/m².
  • Tumor-related acute obstruction, active major hemorrhage, or perforation requiring emergency surgery.
  • Preoperative confirmation of synchronous multiple gastric cancers or remnant gastric cancer, or the presence or history within the preceding 5 years of another active malignancy that may interfere with study treatment or assessment of study endpoints.
  • Preoperative assessment indicating that radical distal gastrectomy is oncologically or technically inappropriate, including anticipated requirement for total gastrectomy, proximal gastrectomy, combined esophagectomy, or any other procedure other than distal gastrectomy.
  • Preoperative evaluation or diagnostic laparoscopy demonstrating definite invasion of adjacent organs requiring en bloc multivisceral resection; distant metastasis, including peritoneal, hepatic, pulmonary, osseous, or distant lymph-node metastasis; or positive peritoneal lavage cytology.
  • Standard preoperative evaluation indicating that the patient is not currently an appropriate candidate for upfront radical distal gastrectomy and requires initiation or continuation of neoadjuvant therapy or other antineoplastic treatment.
  • Concomitant disease requiring an additional surgical procedure at the time of radical gastrectomy that may substantially affect operative duration, perioperative safety, postoperative recovery, or assessment of the primary endpoint.
  • Pregnancy or lactation, or planned pregnancy during the study period.
  • Severe cardiac, pulmonary, hepatic, or renal dysfunction; severe coagulation abnormalities; uncontrolled infection; or any other medical condition considered to preclude safe administration of general anesthesia or surgical treatment.
  • Inability to provide valid informed consent because of cognitive impairment, psychiatric or mental status abnormalities, or other reasons, or inability to comply with protocol-specified treatment and follow-up procedures.
  • Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

PLA Army Characteristic Medical Center

Chongqing, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Xian Shen, PhD

CONTACT

+86 139 6888 8872shenxian1120@126.com

Qiantong Dong, PhD

CONTACT

+86 13676449760dongqt2021@wmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 18, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations

CN(5)