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RecruitingNCT06929949STARS-GC10Updated Aug 28, 2026

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

An observational study in Gastroesophageal Junction (GEJ) Cancer and Gastric Cancer, sponsored by The First Hospital of Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by The First Hospital of Jilin University · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 75 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Gastroesophageal Junction (GEJ) Cancer
  • Gastric Cancer

Keywords

  • Robot-assisted surgery
  • Laparoscopic-assisted surgery
  • Proximal gastrectomy
  • Digestive tract reconstruction
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 90 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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).

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

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What researchers measure

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).

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

Secondary outcomes

  1. 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.

    Time frame: Within 30 days after surgery

  2. 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.

    Time frame: Within 30 days after surgery

  3. Body weight change

    Body weight will be monitored during follow-up after surgery.

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  4. Long-term postoperative quality of life

    Quality of life was assessed by EORTC QLQ-STO22 questionnaires.

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  5. Long-term postoperative quality of life

    Quality of life was assessed by EORTC QLQ-C30 questionnaires.

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  6. Postoperative albumin

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  7. Postoperative prealbumin

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  8. Postoperative total protein

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  9. Postoperative hemoglobin

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  10. Vitamin D

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  11. Folic acid

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  12. Vitamin B12

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  13. Ferritin

    Hematological examination

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  14. Sarcopenia

    CT scan was performed to assess the L3 skeletal muscle index (LSMI).

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  15. Hp Infection

    C13/14 examination by blowing or by endoscopic biopsy.

    Time frame: Follow-up evaluations are performed up to 2 years postoperatively.

  16. 3-years Relapse free survival rate

    Time frame: Follow-up evaluations are performed up to 3 years postoperatively.

  17. 3-years overall survival rate

    Time frame: Follow-up evaluations are performed up to 3 years postoperatively.

07

Study locations

1 of 1 sites recruiting
  • First Hospital of Jilin University
    Changchun, Jilin 130012, China
    • Quan Director, clinical professor, M.D. · Contact · wquan@jlu.edu.cn · +86 15843073207
    Recruiting
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References and documents

Publications

  • 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. PubMed 27094564 ↗
  • 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. PubMed 27157920 ↗
  • 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. PubMed 38204447 ↗
  • 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. PubMed 36790808 ↗
  • 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. PubMed 30203207 ↗
  • 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. PubMed 28342130 ↗
  • 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. PubMed 30788750 ↗
  • 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. PubMed 33118118 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06929949
Lead sponsor
The First Hospital of Jilin University
Responsible party
Quan Wang (Director, Clinical Professor, The First Hospital of Jilin University) — Principal investigator
First posted
Apr 16, 2025
Start date
Nov 25, 2024
Primary completion
Nov 25, 2028 (estimated)
Completion
Nov 25, 2030 (estimated)
Last update
Aug 28, 2026

Study contacts

Quan Wang, Professor
Contact
wquan@jlu.edu.cn
+86 15843073207

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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