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Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

ConditionsGastroesophageal Junction CancerStomach NeoplasmsEsophageal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNurettin Şahin

About this trial

This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 90 years

Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer

Considered operable after multidisciplinary tumor board evaluation

Candidate for curative surgical resection with D2 lymphadenectomy

Disqualifiers

Early-stage gastroesophageal junction cancer

Gastric cancers located in the antrum or corpus

Severe anesthetic risk (American Society of Anesthesiologists [ASA] class IV or higher)

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proximal Gastrectomy

    Procedure/Surgery

    Proximal gastrectomy with D2 lymphadenectomy involving resection of the proximal stomach and gastroesophageal junction. Reconstruction will be performed using esophagogastric or esophagojejunal anastomosis according to surgeon preference. The procedure may be performed via open, laparoscopic, or robotic approach depending on patient suitability.

  • Total Gastrectomy

    Procedure/Surgery

    Total gastrectomy with D2 lymphadenectomy involving complete removal of the stomach followed by esophagojejunal reconstruction. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Proximal GastrectomyExperimental treatment 1 intervention
Group B: Total GastrectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-Year Disease-Free Survival

Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.

Time frame
3 years

Secondary outcomes

1

Postoperative Mortality

All-cause mortality occurring within 90 days after surgery.

Time frame
90 days
2

Postoperative Complications

Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications.

Time frame
90 days
3

Number of Metastatic Lymph Nodes

Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery.

Time frame
At time of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nurettin Şahin

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Sponsor institution

Ankara City Hospital Bilkent

Collaborator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Collaborator

Istanbul University - Cerrahpasa

Collaborator

Source ClinicalTrials.gov
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