Gastroesophageal Junction (GEJ) CancerSTARS-GC10NCT06929949
The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
An observational study of Gastroesophageal Junction (GEJ) Cancer and Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Junction (GEJ) Cancer, Gastric Cancer
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2024to 25 Nov 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0 according to the AJCC 8th edition) and esophageal junction cancer (≤4cm in diameter).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130012
Quan Director, clinical professor, M.D., +86 15843073207, wquan@jlu.edu.cn
About this study
Official title: 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.
Read more
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
- Keywords
- Robot-assisted surgery, Laparoscopic-assisted surgery, Proximal gastrectomy, Digestive tract reconstruction
- Medical subject headings
- Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reflux esophagitis
The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Secondary outcomes (17)
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.
Measured: 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.
Measured: Within 30 days after surgery
Body weight change
Body weight will be monitored during follow-up after surgery.
Measured: 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.
Measured: 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.
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative albumin
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative prealbumin
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative total protein
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative hemoglobin
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin D
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Folic acid
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin B12
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Ferritin
Hematological examination
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Sarcopenia
CT scan was performed to assess the L3 skeletal muscle index (LSMI).
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
Hp Infection
C13/14 examination by blowing or by endoscopic biopsy.
Measured: Follow-up evaluations are performed up to 2 years postoperatively.
3-years Relapse free survival rate
Measured: Follow-up evaluations are performed up to 3 years postoperatively.
3-years overall survival rate
Measured: Follow-up evaluations are performed up to 3 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start25 Nov 2024
- Primary completion25 Nov 2028 (estimated)
- Study completion25 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Junction (GEJ) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929949
- Sponsor's protocol ID
- STARS-GC10
- Acronym
- STARS-GC10
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 27094564Kuroda 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 27157920Zhang 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 38204447Park 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 36790808Cho 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 30203207Jung 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 28342130Katai 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 30788750Yamasaki 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
- ClinicalTrials.gov ID
- NCT06929949
- Acronym / sponsor ID
- STARS-GC10 / STARS-GC10
- Keywords
- Robot-assisted surgery, Laparoscopic-assisted surgery, Proximal gastrectomy, Digestive tract reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Nov 2028 (estimated)
- Study completion
- 25 Nov 2030 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0 according to the AJCC 8th edition) and esophageal junction cancer (≤4cm in diameter).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of reflux esophagitis
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).
17 secondary outcomes
Incidence of Postoperative complications
Time frame: Within 30 days after surgery
Postoperative mortality
Time frame: Within 30 days after surgery
Body weight change
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Long-term postoperative quality of life
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Long-term postoperative quality of life
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative albumin
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative prealbumin
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative total protein
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Postoperative hemoglobin
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin D
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Folic acid
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Vitamin B12
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Ferritin
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Sarcopenia
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hp Infection
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
3-years Relapse free survival rate
Time frame: Follow-up evaluations are performed up to 3 years postoperatively.
3-years overall survival rate
Time frame: Follow-up evaluations are performed up to 3 years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 27094564Muraoka 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.
- Background: PubMed 27157920Kuroda 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.
- Background: PubMed 38204447Zhang 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.
- Background: PubMed 36790808Park 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.
- Background: PubMed 30203207Cho 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.
- Background: PubMed 28342130Jung 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.
- Background: PubMed 30788750Katai 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.
- Background: PubMed 33118118Yamasaki 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Junction (GEJ) Cancer and Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Wang, Professor (+86 15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reflux esophagitis (time frame: Follow-up evaluations are performed up to 2 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06929949, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.