Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer

NCT07790809 | Recruiting

• 1 other identifier: Carina-GEJ-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma is a challenging malignancy located at the anatomical transition between the esophagus and stomach. Due to its complex anatomical location and mixed biological characteristics of esophageal and gastric cancers, the optimal surgical strategy remains controversial. Current surgical approaches vary in terms of operative access, extent of resection, and lymph node dissection. Although minimally invasive laparoscopic and integrated robotic surgery have demonstrated potential advantages in improving perioperative outcomes, limitations remain when managing complex procedures involving both abdominal and mediastinal fields. Split-type robotic surgical systems, characterized by independently movable robotic carts, provide greater flexibility in robotic arm positioning and may overcome some limitations associated with conventional integrated robotic platforms, particularly in extensive multi-quadrant procedures requiring simultaneous abdominal and mediastinal lymph node dissection. However, clinical evidence regarding the safety and effectiveness of split-type robotic surgery for Siewert type II/III GEJ cancer remains limited. This prospective single-arm clinical study aims to evaluate the feasibility, safety, and short-term surgical outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will assess perioperative outcomes, including operative characteristics, postoperative complications, lymph node dissection quality, and short-term recovery parameters. The findings of this study are expected to provide preliminary clinical evidence regarding the application of split-type robotic technology in complex GEJ cancer surgery and support future large-scale clinical investigations.

Conditions

Siewert Type II/III Gastroesophageal Junction Adenocarcinoma

Keywords

Gastroesophageal Junction Adenocarcinoma; Siewert Type II/III; Modular Robotic Surgery; Minimally Invasive Surgery; Lymph Node Dissection

Outcome Measures

Primary Outcomes (2)

• Rate of Successful Completion of Robotic Surgery Without Conversion

  The proportion of patients who successfully complete radical resection using the Carina modular robotic surgical system without conversion to conventional laparoscopy or open surgery. Conversion includes unplanned transition to another surgical approach due to technical difficulties, intraoperative complications, or inability to complete the planned robotic procedure.

  Intraoperatively

• Incidence of Perioperative Complications (Clavien-Dindo Classification)

  The incidence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system. Complications include surgical and medical adverse events occurring during the perioperative period.

  Within 30 days after surgery

Secondary Outcomes (24)

• Achievement Rate of D2 Lymphadenectomy

  Perioperative/Periprocedural

• Number and Metastatic Rate of Lymph Nodes in the Lower Mediastinal and Suprapancreatic Regions

  Within 14 days after surgery (pathological assessment)

• Postoperative Pathological Stage (pTNM Classification)

  Within 14 days after surgery

• R0 Resection Rate

  Within 14 days after surgery

• Proximal and Distal Resection Margin Distance

  Within 14 days after surgery

Study Arms (1)

Carina Robotic Surgery Group

EXPERIMENTAL

Patients with Siewert type II/III gastroesophageal junction adenocarcinoma who undergo radical surgical resection assisted by the Carina modular surgical robotic system. All participants will receive the same robotic surgical intervention, and perioperative safety, surgical outcomes, pathological outcomes, and short-term postoperative recovery will be evaluated prospectively.

Procedure: Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer

Interventions

Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer PROCEDURE

Patients will undergo totally robotic-assisted radical surgery for Siewert type II/III gastroesophageal junction cancer. The surgical procedure includes robotic-assisted tumor resection and lymph node dissection according to standard oncologic principles.

Carina Robotic Surgery 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 80 years, inclusive, regardless of sex.
• Histologically and/or cytologically confirmed Siewert type II or type III gastroesophageal junction tumor, with clinical staging according to AJCC 8th edition TNM classification indicating suitability for curative surgical resection.
• Adequate organ function as assessed by the investigator before surgery.
• Provision of written informed consent and willingness to participate in the study.
• Ability and willingness to comply with study procedures and follow-up requirements.
• ECOG performance status of 0-1.
• Absence of distant metastasis confirmed by preoperative thoracoabdominal and pelvic CT or PET-CT.

You may not qualify if:

• Patients with body mass index (BMI) \<18.5 kg/m² or BMI ≥35 kg/m².
• Patients with severe cardiac, pulmonary, neurological, hepatic, or renal diseases that may prevent tolerance of surgery or anesthesia.
• Patients unable to tolerate pneumoperitoneum or considered by the investigator to have extensive intra-abdominal adhesions or other conditions preventing safe establishment of pneumoperitoneum.
• Patients with severe coagulation disorders that contraindicate minimally invasive surgery.
• Patients with active pulmonary tuberculosis.
• Patients with severe uncontrolled diseases, acute infections, severe physical deterioration, massive ascites, active intra-abdominal bleeding, or shock.
• Patients with metastatic lymph nodes fused together or encasing major blood vessels, making curative resection infeasible.
• Patients with previous abdominal/pelvic surgery, radiotherapy, or chemotherapy that may affect the feasibility of laparoscopic or robotic surgery.
• Pregnant or breastfeeding women.
• Patients currently participating in other clinical trials involving investigational drugs or medical devices.
• Patients considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin Universiry

Changchun, Jilin, 130021, China

RECRUITING

Central Study Contacts

Quan Wang

CONTACT

+86 15843073207; wquan@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)