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

8. maj 2026 opdateret af: First Affiliated Hospital of Wenzhou Medical University

A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single-Port Group
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.
Enhed: Single-Port Robotic Surgical System
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.
Aktiv komparator: Traditional Laparoscopy Group
Procedure: Traditional Laparoscopic Surgery
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
Tidsramme: Within 30 days postoperatively.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Blood Loss
Tidsramme: During the surgical procedure (Day 0).
The amount of blood lost during the surgical procedure, measured in milliliters (mL).
During the surgical procedure (Day 0).
Time to First Flatus
Tidsramme: Up to 30 days postoperatively.
The time from the end of surgery until the participant's first passage of flatus, measured in days.
Up to 30 days postoperatively.
Total Operation Time
Tidsramme: During the surgical procedure (Day 0).
The duration from the initial skin incision to the completion of skin closure, measured in minutes.
During the surgical procedure (Day 0).
Conversion Rate
Tidsramme: During the surgical procedure (Day 0).
The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors.
During the surgical procedure (Day 0).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. november 2025

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2025-143
  • ChiCTR2500109905 (Anden identifikator: Chinese Clinical Trial Registry)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Single-Port Robotic Surgical System

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