Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06929949

The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy

Led by The First Hospital of Jilin University · Updated on 2025-04-16

90

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes. For early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques. Several reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients. Most existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l

CONDITIONS

Official Title

The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 and under 75 years
  • Histologically confirmed carcinoma or adenoma by preoperative gastroscopic biopsy
  • Diagnosed with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0) or esophagogastric junction cancer with a tumor diameter 4 cm or less
  • Scheduled for proximal gastrectomy with D2 lymphadenectomy aiming for curative resection
  • Remaining stomach volume expected to be at least half of pre-resection volume
  • ECOG performance status 0 or 1
  • ASA class I to III
  • Adequate organ function and ability to tolerate surgery
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy
  • Multiple malignant tumors in the stomach
  • History of upper abdominal surgery except laparoscopic cholecystectomy
  • History of gastric surgery except endoscopic submucosal dissection or mucosal resection for gastric cancer
  • Evidence of distant metastasis on imaging tests
  • Pregnant or breastfeeding women
  • History of uncontrolled epilepsy, CNS disorders, or psychiatric illness
  • Limb disabilities or motor function impairment
  • History of other malignant diseases within past five years except cured skin cancer and cervical carcinoma in situ
  • Severe active heart disease or recent myocardial infarction
  • Stroke or cerebral hemorrhage within past six months
  • Severe uncontrolled infections or other serious comorbidities
  • Pulmonary function test showing FEV1 less than 50% predicted
  • Require emergency surgery for tumor complications such as bleeding, perforation, or obstruction

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Hospital of Jilin University

Changchun, Jilin, China, 130012

Actively Recruiting

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Research Team

Q

Quan Wang, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy | DecenTrialz