Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial

NCT07586384 | Recruiting

• 2 other identifiers: KY2025-143ChiCTR2500109905
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.

Conditions

Stomach Neoplasms; Robotic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)

  The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.

  Within 30 days postoperatively.

Secondary Outcomes (4)

• Estimated Blood Loss

  During the surgical procedure (Day 0).

• Time to First Flatus

  Up to 30 days postoperatively.

• Total Operation Time

  During the surgical procedure (Day 0).

• Conversion Rate

  During the surgical procedure (Day 0).

Study Arms (2)

Single-Port Group

EXPERIMENTAL

Participants in this group will undergo radical proximal gastrectomy utilizing the SP1000 single-port surgical platform. The procedure focuses on performing the main surgical maneuvers through a centralized access point to evaluate the safety and clinical performance of the robotic system.

Device: Single-Port Robotic Surgical System

Traditional Laparoscopy Group

ACTIVE COMPARATOR

Procedure: Traditional Laparoscopic Surgery

Interventions

Single-Port Robotic Surgical System DEVICE

An investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.

Single-Port Group

Traditional Laparoscopic Surgery PROCEDURE

Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.

Traditional Laparoscopy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years inclusive.
• ECOG performance status ≤ 2.
• Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction.
• Clinical stage cT1-T3, N0-N+, M0.
• Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm.
• Candidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis.
• Assessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy.
• Radiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI).
• ASA physical status classification ≤ III.
• Adequate bone marrow, hepatic, renal, cardiac, and pulmonary function.
• Ability to understand and provide written informed consent.
• Willingness and ability to comply with the 12-month postoperative follow-up schedule.

You may not qualify if:

• Clinical stage T4 or presence of distant metastasis.
• Esophageal invasion exceeding 2 cm.
• History of previous major gastric surgery (e.g., partial or total gastrectomy).
• Other malignant tumors within the last 5 years.
• Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis).
• Requirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction.
• Pregnant or lactating women.
• Serious psychiatric disorders or cognitive impairment that interferes with study compliance.
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xian Shen

CONTACT

+86 139 6888 8872; shenxian1120@126.com

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: May 8, 2026
• First Posted: May 14, 2026
• Study Start: November 5, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

CN (1)