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

NCT06929949 | Recruiting

• 1 other identifier: STARS-GC10
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastroesophageal Junction (GEJ) Cancer; Gastric Cancer

Keywords

Robot-assisted surgery; Laparoscopic-assisted surgery; Proximal gastrectomy; Digestive tract reconstruction

Outcome Measures

Primary Outcomes (1)

• Incidence of reflux esophagitis

  The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).

  Follow-up evaluations are performed up to 2 years postoperatively.

Secondary Outcomes (17)

• Incidence of Postoperative complications

  Within 30 days after surgery

• Postoperative mortality

  Within 30 days after surgery

• Body weight change

  Follow-up evaluations are performed up to 2 years postoperatively.

• Long-term postoperative quality of life

  Follow-up evaluations are performed up to 2 years postoperatively.

• Long-term postoperative quality of life

  Follow-up evaluations are performed up to 2 years postoperatively.

Study Arms (3)

Double-flap technique (DFT)

The DFT digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy

double-tract reconstruction (DTR)

The DTR digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy

Tubular gastric anastomosis (TGA)

The TGA digestive tract reconstruction was performed in patients with gastroesophageal cancer after proximal gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0 according to the AJCC 8th edition) and esophageal junction cancer (≤4cm in diameter).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130012, China

RECRUITING

Related Publications (8)

• Muraoka 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 BACKGROUND

• Kuroda 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 BACKGROUND

• Zhang 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 BACKGROUND

• Park 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 BACKGROUND

• Cho 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 BACKGROUND

• Jung 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.

  PMID: 28342130 BACKGROUND

• Katai H, Mizusawa J, Katayama H, Kunisaki C, Sakuramoto S, Inaki N, Kinoshita T, Iwasaki Y, Misawa K, Takiguchi N, Kaji M, Okitsu H, Yoshikawa T, Terashima M; Stomach Cancer Study Group of Japan Clinical Oncology Group. Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401. Gastric Cancer. 2019 Sep;22(5):999-1008. doi: 10.1007/s10120-019-00929-9. Epub 2019 Feb 20.

  PMID: 30788750 BACKGROUND

• Yamasaki M, Takiguchi S, Omori T, Hirao M, Imamura H, Fujitani K, Tamura S, Akamaru Y, Kishi K, Fujita J, Hirao T, Demura K, Matsuyama J, Takeno A, Ebisui C, Takachi K, Takayama O, Fukunaga H, Okada K, Adachi S, Fukuda S, Matsuura N, Saito T, Takahashi T, Kurokawa Y, Yano M, Eguchi H, Doki Y. Multicenter prospective trial of total gastrectomy versus proximal gastrectomy for upper third cT1 gastric cancer. Gastric Cancer. 2021 Mar;24(2):535-543. doi: 10.1007/s10120-020-01129-6. Epub 2020 Oct 29.

  PMID: 33118118 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Quan Wang, Professor

CONTACT

+86 15843073207; wquan@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 16, 2025
• Study Start: November 25, 2024
• Primary Completion (Estimated): November 25, 2028
• Study Completion (Estimated): November 25, 2030
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)