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NCT Number: NCT07482566

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Turgut Donmez, MD

CONTACT

[email protected]

+905347400967

About this study

Gastroesophageal junction cancers represent a challenging oncological entity, particularly in patients with locally advanced Siewert type II-III tumors. Total gastrectomy has traditionally been considered the standard surgical treatment; however, proximal gastrectomy has gained increasing interest in recent years due to potential advantages in postoperative functional outcomes and reduced surgical morbidity. Nevertheless, concerns remain regarding the adequacy of oncological clearance and lymph node dissection with proximal gastrectomy.

This multicenter prospective randomized clinical trial is designed to evaluate the safety, feasibility, and oncological outcomes of proximal gastrectomy compared with total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Patients diagnosed through endoscopic and histopathological evaluation and deemed operable after multidisciplinary tumor board discussion will be included. Following informed consent, participants will be randomized in a parallel design to undergo either proximal gastrectomy or total gastrectomy with D2 lymph node dissection (D2 lymphadenectomy). Surgical procedures may be performed via open, laparoscopic, or robotic approaches based on surgeon preference and patient suitability.

Baseline demographic characteristics, perioperative variables, pathological findings, postoperative morbidity and mortality, and long-term oncological outcomes will be prospectively recorded. The primary endpoint is 3-year disease-free survival (DFS), while secondary endpoints include postoperative complications, mortality, and the number of metastatic lymph nodes. Patients will be followed at predefined intervals for up to five years after surgery. The results of this study are expected to provide high-level evidence to guide surgical decision-making in the management of locally advanced gastroesophageal junction cancers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Provision of written informed consent

Exclusion criteria

  • 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
  • Patients unwilling or unable to provide informed consent

Treatment and study plan

proximal gastrectomy

Procedure

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

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.

Primary outcomes

  1. 3-Year Disease-Free Survival

    Time frame: 3 years

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

Secondary outcomes

  1. Postoperative Mortality

    Time frame: 90 days

    All-cause mortality occurring within 90 days after surgery.

  2. Postoperative Complications

    Time frame: 90 days

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

  3. Number of Metastatic Lymph Nodes

    Time frame: At time of surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Tolga Dinc, MD

CONTACT

[email protected]

+90 5324812275

Turgut Donmez, MD

CONTACT

[email protected]

+90 5347400967

Sponsors and collaborators

Lead sponsor

Nurettin Şahin

Other Gov

Collaborators

  • Ankara City Hospital Bilkent
  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Istanbul University - Cerrahpasa

Registry information

Official study title

A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Proximal Gastrectomy and Total Gastrectomy in Patients With Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

Acronym: SIEWERT-RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Mar 19, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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