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Single-incision plus one-port laparoscopic surgery (SILS+1) versus conventional laparoscopic surgery for the treatment of esophagogastric junction adenocarcinoma (GEJA): a multicenter, prospective, open-label, non-inferiority, randomized controlled study

Single-incision plus one-port laparoscopic surgery (SILS+1) versus conventional laparoscopic surgery for the treatment of esophagogastric junction adenocarcinoma (GEJA): a multicenter, prospective, open-label, non-inferiority, randomized controlled study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099632
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagogastric junctional adenocarcinoma

Interventions

Conventional Laparoscopy Surgery Group:Conventional multi-port laparoscopic total gastrectomy, esophageal-jejunostomy, and D2 lymph node dissection
Single-incision plus one-port Laparoscopic Surgery:Single-incision plus one-port laparoscopic total gastrectomy, esophageal-jejunostomy, D2 lymph node dissection

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: A. Aged 18-85 years; B. Pathological diagnosis of the primary lesion as adenocarcinoma (e.g., papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, mixed adenocarcinoma, etc.); C. Confirmed by gastroscopy as Siewert type II or III adenocarcinoma of the esophagogastric junction, with preoperative imaging assessment indicating the possibility of radical resection; D. Preoperative ASA (American Society of Anesthesiologists) score: I-III; E. Clinical stage: T1-4aN0-3M0 (based on the AJCC 8th Edition Cancer Staging Manual, regardless of whether preoperative neoadjuvant therapy was administered); F. BMI (Body Mass Index) < 30 kg/m^2; G. The patient has provided written informed consent.

Exclusion criteria

Exclusion criteria: A. Previous gastrointestinal surgery; B. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; C. Multiple malignant diseases; D. Women who are pregnant or breastfeeding; E. Severe mental illness; F. Severe liver or kidney dysfunction, coagulation disorders, or significant comorbidities that render the patient unable to tolerate surgery; G. Preoperative body temperature >= 38°C or presence of infectious diseases requiring systemic treatment; H. Severe respiratory diseases; I. Unstable angina or a history of myocardial infarction within the past 6 months; J. History of cerebral infarction or cerebral hemorrhage within the past 6 months; K. Continuous systemic corticosteroid therapy within the past month (excluding topical use); L. History of major upper abdominal surgery (excluding laparoscopic cholecystectomy); M. The patient is currently participating or has participated in other clinical trials within the past 6 months.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival;

Secondary

MeasureTime frame
Perioperative complication rate;Surgical quality ;3-year overall survival;

Countries

China

Contacts

Public ContactShoujiang Wei

Affiliated Hospital of North Sichuan Medical College

wshj26467@21cn.com+86 139 9089 8624

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026