Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Xian Shen
- Telefonnummer: +86 139 6888 8872
- E-post: shenxian1120@126.com
Studieorter
-
-
Zhejiang
-
Wenzhou, Zhejiang, Kina
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
-
Kontakt:
- Xian Shen
- Telefonnummer: +86 139 6888 8872
- E-post: shenxian1120@126.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Estimated Blood Loss
Tidsram: During the surgical procedure (Day 0).
|
The amount of blood lost during the surgical procedure, measured in milliliters (mL).
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During the surgical procedure (Day 0).
|
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Time to First Flatus
Tidsram: Up to 30 days postoperatively.
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The time from the end of surgery until the participant's first passage of flatus, measured in days.
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Up to 30 days postoperatively.
|
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Total Operation Time
Tidsram: 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).
|
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Conversion Rate
Tidsram: During the surgical procedure (Day 0).
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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).
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KY2025-143
- ChiCTR2500109905 (Annan identifierare: Chinese Clinical Trial Registry)
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