The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy (STARS-GC10)

A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Gastroesophageal Junction (GEJ) Cancer

Detailed Description

Gastric cancer is the fifth most common malignant tumor worldwide and ranks fourth in cancer-related mortality. In China, the incidence and mortality rate of gastric cancer rank third among all malignancies. While the global incidence of gastric cancer has been steadily declining, the incidence of proximal gastric cancer has been rising. Additionally, the incidence of adenocarcinoma of the esophagogastric junction (AEG) has been increasing annually, showing an upward trend worldwide. Due to its unique anatomical location and significant tumor biological heterogeneity, there is no standardized consensus on the optimal treatment for AEG. Therefore, selecting an appropriate surgical resection and reconstruction approach remains crucial for improving the prognosis of patients with proximal gastric cancer and AEG.

For early-stage proximal gastric cancer and AEG, either total gastrectomy (TG) or proximal gastrectomy (PG) can be performed. With the advancement of function-preserving surgical concepts, PG has been increasingly recognized as a viable option. The Japanese Clinical Oncology Group (JCOG1401) trial demonstrated that laparoscopic proximal gastrectomy (LPG) is a safe and effective treatment for early-stage proximal gastric cancer compared to laparoscopic total gastrectomy (LTG). However, patients undergoing TG often experience long-term postoperative quality-of-life concerns. Although TG can effectively remove lymph nodes and reduce the risk of gastroesophageal reflux, it results in the permanent loss of gastric storage, mechanical grinding, and secretory functions, as well as reduced feasibility of postoperative endoscopic examination. TG patients may also suffer from nutritional deficiencies, including vitamin B12 deficiency, iron deficiency, weight loss, anemia, diarrhea, and dumping syndrome. In contrast, PG offers advantages in preserving gastrointestinal function and nutritional status. However, its widespread adoption is limited by the risk of reflux esophagitis. Thus, selecting an optimal reconstruct

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Quan Wang, Professor; Phone Number: +86 15843073207; Email: wquan@jlu.edu.cn

Study Locations

• China
  • Jilin
    • ChangChun, Jilin, China, 130012
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Quan Director, clinical professor, M.D.; Phone Number: +86 15843073207; Email: wquan@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative complications	The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients with any postoperative complication was used as the numerator to calculate the incidence percentage.	Within 30 days after surgery
Postoperative mortality	The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients who died after surgery was used as the numerator to calculate the incidence percentage.	Within 30 days after surgery
Body weight change	Body weight will be monitored during follow-up after surgery.	Follow-up evaluations are performed up to 2 years postoperatively.
Long-term postoperative quality of life	Quality of life was assessed by EORTC QLQ-STO22 questionnaires.	Follow-up evaluations are performed up to 2 years postoperatively.
Long-term postoperative quality of life	Quality of life was assessed by EORTC QLQ-C30 questionnaires.	Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative albumin	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative prealbumin	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative total protein	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative hemoglobin	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin D	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Folic acid	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin B12	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Ferritin	Hematological examination	Follow-up evaluations are performed up to 2 years postoperatively.
Sarcopenia	CT scan was performed to assess the L3 skeletal muscle index (LSMI).	Follow-up evaluations are performed up to 2 years postoperatively.
Hp Infection	C13/14 examination by blowing or by endoscopic biopsy.	Follow-up evaluations are performed up to 2 years postoperatively.
3-years Relapse free survival rate		Follow-up evaluations are performed up to 3 years postoperatively.
3-years overall survival rate		Follow-up evaluations are performed up to 3 years postoperatively.

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): November 25, 2028
• Study Completion (Estimated): November 25, 2030

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Proximal gastrectomy; Robot-assisted surgery; Laparoscopic-assisted surgery; Digestive tract reconstruction
• Other Study ID Numbers: STARS-GC10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No