Clinical trial · Observational
The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction (GEJ) Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Double-flap technique (DFT)
- description
- The DFT digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy
- label
- double-tract reconstruction (DTR)
- description
- The DTR digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy
- label
- Tubular gastric anastomosis (TGA)
- description
- The TGA digestive tract reconstruction was performed in patients with gastroesophageal cancer after proximal gastrectomy
Primary outcomes (1)
- measure
- Incidence of reflux esophagitis
- timeFrame
- Follow-up evaluations are performed up to 2 years postoperatively.
- description
- The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age from over 18 to under 75 years. * Preoperative gastroscopic pathological biopsy was performed, and histologically confirmed as carcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma, etc.) or adenoma. * Diagnosed with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0) or esophagogastric junction cancer with a diameter ≤4 cm based on the 8th edition of the AJCC staging system, as confirmed by CT, MRI, endoscopic ultrasound, and pathology. * Undergoing proximal gastrectomy with D2 lymphadenectomy is expected to achieve curative resection, with the remaining gastric volume required to be at least half of the pre-resection volume. * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale. * ASA (American Society of Anesthesiology) class I to III. * The patient has adequate organ function and is capable of tolerating surgery. * Written informed consent. Exclusion Criteria: * Patients who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy. * Presence of multiple malignant tumors in the stomach. * History of upper abdominal surgery, except for laparoscopic cholecystectomy. * History of gastric surgery, except for endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for gastric cancer. * Evidence of distant metastasis diagnosed by thoracoabdominal CT/MRI or PET-CT. * Pregnant or lactating women. * History of uncontrolled epilepsy, central nervous system disorders, or psychiatric illness. * Patients with limb disabilities or motor function impairment. * History of other malignant diseases within the past five years, except for cured skin cancer and cervical carcinoma in situ. * Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medical intervention, or myocardial infarction within the past six months. * History of stroke or cerebral hemorrhage within the past six months. * Severe, uncontrolled recurrent infections or other serious uncontrolled comorbidities. * Pulmonary function test showing FEV1 \< 50% of the predicted value. * Patients requiring emergency surgery due to tumor-related complications (e.g., bleeding, perforation, or obstruction).
References
Publications (8)
- BACKGROUNDMuraoka A, Kobayashi M, Kokudo Y. Laparoscopy-Assisted Proximal Gastrectomy with the Hinged Double Flap Method. World J Surg. 2016 Oct;40(10):2419-24. doi: 10.1007/s00268-016-3510-5. PMID 27094564
- BACKGROUNDKuroda S, Nishizaki M, Kikuchi S, Noma K, Tanabe S, Kagawa S, Shirakawa Y, Fujiwara T. Double-Flap Technique as an Antireflux Procedure in Esophagogastrostomy after Proximal Gastrectomy. J Am Coll Surg. 2016 Aug;223(2):e7-e13. doi: 10.1016/j.jamcollsurg.2016.04.041. Epub 2016 May 6. No abstract available. PMID 27157920
- BACKGROUNDZhang Y, Zhang H, Yan Y, Ji K, Jia Z, Yang H, Fan B, Wang A, Wu X, Zhang J, Ji J, Ji X, Bu Z. Double-tract reconstruction is superior to esophagogastrostomy in controlling reflux esophagitis and enhancing quality of life after proximal gastrectomy: Results from a prospective randomized controlled clinical trial in China. Chin J Cancer Res. 2023 Dec 30;35(6):645-659. doi: 10.21147/j.issn.1000-9604.2023.06.09. PMID 38204447
- BACKGROUNDPark DJ, Han SU, Hyung WJ, Hwang SH, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee I, Suh YS, Park JH, Ahn S, Park YS, Kim HH. Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12 Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2256004. doi: 10.1001/jamanetworkopen.2022.56004. PMID 36790808
- BACKGROUNDCho M, Son T, Kim HI, Noh SH, Choi S, Seo WJ, Roh CK, Hyung WJ. Similar hematologic and nutritional outcomes after proximal gastrectomy with double-tract reconstruction in comparison to total gastrectomy for early upper gastric cancer. Surg Endosc. 2019 Jun;33(6):1757-1768. doi: 10.1007/s00464-018-6448-x. Epub 2018 Sep 10. PMID 30203207
- BACKGROUNDJung DH, Lee Y, Kim DW, Park YS, Ahn SH, Park DJ, Kim HH. Laparoscopic proximal gastrectomy with double tract reconstruction is superior to laparoscopic total gastrectomy for proximal early gastric cancer. Surg Endosc. 2017 Oct;31(10):3961-3969. doi: 10.1007/s00464-017-5429-9. Epub 2017 Mar 24.