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NCT Number: NCT07635836

Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer

This study includes patients diagnosed with proximal gastric cancer (Siewert type II/III, cT1-3N0-1M0) across six tertiary hospitals, who underwent either double-tract reconstruction (DTR) or tubular gastric anastomosis (TGA). Participants were divided into two groups based on the surgical procedure. We conducted a comparative analysis of postoperative outcomes by evaluating electronic medical records, postoperative gastroscopy, 24-hour esophageal pH monitoring, and relevant rating scales.

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Key information

Conditions

Gastric Cancer (GC) Digestive System Diseases Digestive System Neoplasms Double-tract Reconstruction Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Tubular Gastric Anastomosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Hui Qu, Doctor of Medicine

CONTACT

[email protected]

+8618560085120

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologically confirmed gastric adenocarcinoma by biopsy
  • Carcinoma of the upper gastric body or Siewert type II/III adenocarcinoma of the esophagogastric junction (AEG), with a clinical stage of cT1-3N0-1M0
  • Age 18-75 years, with a performance status (PS) score of 0-2
  • Candidates for planned surgical resection, eligible for either double-tract reconstruction or tubular gastric anastomosis based on preoperative assessment
  • No severe dysfunction of vital organs (liver, kidney, heart, lung, or brain), and no severe infection or uncontrolled chronic diseases

Exclusion criteria

  • Presence of other malignant tumors or severe chronic diseases (e.g., severe diabetes mellitus, chronic kidney disease, decompensated cirrhosis, etc.)
  • Preoperative endoscopic diagnosis of Barrett's esophagus
  • Severe preoperative malnutrition (albumin <30 g/L, prealbumin <150 mg/L)
  • History of prior upper abdominal surgery, gastrointestinal malformation, or psychiatric disorders
  • Preoperative diagnosis of obstructive motor disorders of the cardia (including achalasia spectrum disorders)
  • Inability to cooperate with or complete the required postoperative examinations

Treatment and study plan

Double-tract reconstruction

Procedure

Patients underwent double-tract reconstruction after radical proximal gastrectomy

Primary outcomes

  1. Incidence of postoperative reflux esophagitis

    Time frame: 6 month after surgery

    The diagnosis of reflux esophagitis was based on symptoms, endoscopic findings, and 24-hour esophageal pH monitoring.

  2. Severity of reflux esophagitis

    Time frame: 6 month after surgery

    According to the diagnostic and grading criteria for reflux esophagitis, patients were classified into four categories: no reflux esophagitis, mild (LA-A/B), moderate (LA-C), and severe (LA-D).

Secondary outcomes

  1. Postoperative nutritional recovery

    Time frame: 1 year after surgery

    The body weight change rate at different postoperative time points compared with preoperative levels, along with albumin, prealbumin, and hemoglobin levels, were comprehensively considered in the assessment of postoperative nutritional status.

Study contacts

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

Hui Qu, Doctor of Medicine

CONTACT

[email protected]

+8618560085120

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Comparison of Gastroesophageal Reflux and Quality of Life Between Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 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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