Gastric Cancer Patients Undergoing Minimally Invasive GastrectomyNCT06679244
Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study
A study testing Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique and Totally laparoscopic proximal gastrectomy with double-tract reconstruction in people with Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, run by Huashan Hospital at 3 sites in China.
Trial summary
This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
- What is being tested?
- Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique and Totally laparoscopic proximal gastrectomy with double-tract reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesChina
- Study dates
- 4 Dec 2024to Jun 2029
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ 80 years old;
- The primary tumor lesion is located in the upper part of the stomach or the esophagogastric junction (Siewert II or III), and it is expected that R0 surgical results can be obtained by performing proximal gastrectomy and D2 dissection；
- The primary lesion was diagnosed as adenocarcinoma through endoscopic biopsy and histopathological examination;
- If it is upper gastric adenocarcinoma, the clinical TNM staging based on imaging needs to be cT1N0M0. If it is ductal gastric junction adenocarcinoma, it needs to be cT1-3N0-1M0, and clinical imaging judgment shows no distant gastric lymph node metastasis；
- Expected survival exceeds 6 months;
- No history of upper abdominal surgery (excluding laparoscopic cholecystectomy);
Show all 11Show fewer
- No chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. were performed before surgery;
- Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
- Preoperative ASA (American Society of Anesthesiologists) grading I-III ;
- Good function of important organs;
- Sign the patient's informed consent form
Who cannot join
- Preoperative imaging examination suggests the fusion of enlarged lymph nodes (maximum diameter ≥ 3cm) in the area;
- Pregnant and lactating women;
- Suffering from other malignant tumors within 5 years;
- Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
- Serious mental illness;
- Severe respiratory diseases, FEV1<50% of the expected value;
Show all 12Show fewer
- Severe liver and kidney dysfunction;
- History of unstable angina or heart attack within 6 months;
- History of cerebral infarction or cerebral hemorrhage within 6 months, excluding old intracavitary infarction;
- Apply systemic corticosteroid therapy within one month;
- Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
- The patient has participated or is currently participating in other clinical studies (within 6 months)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Lu Zang, doctor, +86 13701752969, zanglu@yeah.net
- Recruiting
Huashan Hospital, Fudan University
Shanghai
Hankun Hao, doctor, +86 18121186328, haohankun@163.com
- Recruiting
Second Department of Gastric Surgery, Fudan University Shanghai Cancer Center,
Shanghai
FengLin Liu, doctor, +86 13918765733, fenglinliu@hotmail.com
About this study
Official title: Application of Hao's Esophagogastrostomy by Fissure Technique: a Prospective, Multicenter Randomized Controlled Study
This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an innovative method named Hao's Esophagogastrostomay by Fisture Technique (HEFT).By adding anti reflux structures such as "false gastric fundus" and "false cardia" to the anastomosis of the residual stomach of the esophagus, not only can the purpose of anti reflux be achieved, but also the normal physiological channel can be maintained, it can fully utilize residual stomach function and reduce the difficulty of surgery.Through retrospective research, our single center has confirmed that HEFT is safe and feasible.On this basis, this study will compare the nutritional status, short- and medium- to long-term safety after laparoscopic HEFT and double-tract reconstruction , in order to evaluate and discover more reasonable digestive tract reconstruction methods after proximal gastrectomy, and to promote the development and popularization of minimally treatment technology for gastric cancer.
This study was jointly conducted by Shanghai-level hospitals (Huashan Hospital ,Shanghai Cancer Center, and Ruijin Hospital), with Huashan Hospital as the leading unit. This study will recruit 52 patients, with 26 patients in the experimental group and 26 patients in the control group. Using a central dynamic randomization method based on minimization, patients are assigned to groups in a 1:1 ratio. Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group).Plan to collect cases for 2 years, and follow up for another year after the last case is enrolled.
The primary endpoint of the study was the body weight loss (BWL) rate at 1 year after surgery. Secondary endpoints: Effect evaluation indicators: hemoglobin level at 1 year after surgery; Serum albumin level at 1 year after surgery; The incidence of anastomotic stenosis 1 year after surgery; Incidence of reflux esophagitis at 1 year after surgery. Evaluation of short-term surgical safety (duration: 7 days): operation time, intraoperative bleeding, anastomotic leakage, pancreatic leakage, and incidence of abdominal infection; Evaluation of medium- and long-term safety after surgery (duration: 36 months): overall survival rate at 3 years after surgery; disease-free survival rate at 3 years after surgery.
- Being tested
- Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique, Totally laparoscopic proximal gastrectomy with double-tract reconstruction
- Keywords
- proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure techniqueProcedure or surgery
This is an innovative surgical method applied in proximal gastrectomy. By adding anti reflux structures such as "false gastric fundus" and "false cardia" on the basis of esophageal residual gastric anastomosis, the goal of anti reflux is achieved, while maintaining normal physiological channels and fully utilizing residual gastric function, reducing the difficulty of proximal gastrectomy surgery
Totally laparoscopic proximal gastrectomy with double-tract reconstructionProcedure or surgery
This is a traditional surgical method that has been widely used in proximal gastrectomy. After disconnecting the proximal stomach, performing Roux-en-Y anastomosis of the esophagus and jejunum firstly, followed by lateral anastomosis of the residual stomach and jejunum. Previous studies have confirmed its safety and effectiveness, but there are also issues of gastric channel disuse and high missed detection rate of residual stomach.
| Study group | Role | What they receive |
|---|---|---|
| Performing Hao's esophagogastrostomy by fissure technique | Experimental | Not described Receives: Procedure: Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique |
| Performing double-tract reconstruction | Active comparator | Not described Receives: Procedure: Totally laparoscopic proximal gastrectomy with double-tract reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight loss（BWL）
Measure the weight before surgery and 1 year after surgery, BWL=(preoperative weight -1 year after surgery weight)/preoperative weight (unit:%)
Measured: From enrollment to 1 year after surgery
Secondary outcomes (11)
Hemoglobin 1 year after surgery
Hemoglobin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.
Measured: 1 year after surgery
Serum albumin 1 year after surgery
Serum albumin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.
Measured: 1 year after surgery
Incidence of anastomotic stenosis 1 year after surgery
Incidence of anastomotic stenosis(%) 1 year after surgery will be used to evaluate operation effect.
Measured: 1 year after surgery
Incidence of reflux esophagitis 1 year after surgery
Incidence of reflux esophagitis 1 year after surgery will be used to evaluate operation effect.
Measured: 1 year after surgery
Duration of surgery
Time spent on the whole operation（minutes）will be used to evaluate short-term safety of the surgery
Measured: intraoperative
Intraoperative blood loss
Intraoperative blood loss(ml) will be used to evalute short-term safety of the surgery.
Measured: Intraoperative
Incidence of anastomotic leakage 7 days after surgery
Incidence of anastomotic leakage(%) 7 days after surgery will be used to evaluate short-term safety of the surgery
Measured: 7 days after surgery
Incidence of pancreatic leakage 7 days after surgery
Incidence of pancreatic leakage 7 days after surgery will be used to evaluate short-term safety of the surgery.
Measured: 7 days after surgery
Incidence of abdominal infection 7 days after surgery
Incidence of abdominal infection 7 days after surgery will be used to evaluate short-term safety of the surgery.
Measured: 7 days after surgery
Overall survival (OS) 3 years after surgery
Overall survival (OS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety
Measured: 3 years after surgery
Disease free survival (DFS) 3 years after surgery
Disease free survival (DFS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety,
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start4 Dec 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Patients Undergoing Minimally Invasive GastrectomyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group). HEFT group:Patients included in this group will receive totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique(HEFT)，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer. double-tract reconstruction group:Patients included in this group will receive totally laparoscopic proximal gastrectomy with double-tract reconstruction group，which is a widely used and proven safe and effective surgical approach in proximal gastrectomy
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Cancer Hospital, China
- Responsible party
- Principal investigator, Hao Hankun, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679244
- Sponsor's protocol ID
- 2024-1173
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakuramoto S, Yamashita K, Kikuchi S, Futawatari N, Katada N, Moriya H, Hirai K, Watanabe M. Clinical experience of laparoscopy-assisted proximal gastrectomy with Toupet-like partial fundoplication in early gastric cancer for preventing reflux esophagitis. J Am Coll Surg. 2009 Sep;209(3):344-51. doi: 10.1016/j.jamcollsurg.2009.04.011. Epub 2009 Jun 18.
PubMed 19717038Aizawa M, Yabusaki H, Nakada K, Matsuki A, Bamba T, Nakagawa S. A Retrospective Review of a Single-Center Experience with Posterolateral Fundoplication During Esophagogastrostomy After Proximal Gastrectomy. J Gastrointest Surg. 2021 Dec;25(12):3230-3233. doi: 10.1007/s11605-021-05052-8. Epub 2021 Jul 8. No abstract available.
PubMed 34240326Shoji Y, Nunobe S, Ida S, Kumagai K, Ohashi M, Sano T, Hiki N. Surgical outcomes and risk assessment for anastomotic complications after laparoscopic proximal gastrectomy with double-flap technique for upper-third gastric cancer. Gastric Cancer. 2019 Sep;22(5):1036-1043. doi: 10.1007/s10120-019-00940-0. Epub 2019 Mar 6.
PubMed 30838469Kuroda S, Choda Y, Otsuka S, Ueyama S, Tanaka N, Muraoka A, Hato S, Kimura T, Tanakaya K, Kikuchi S, Tanabe S, Noma K, Nishizaki M, Kagawa S, Shirakawa Y, Kamikawa Y, Fujiwara T. Multicenter retrospective study to evaluate the efficacy and safety of the double-flap technique as antireflux esophagogastrostomy after proximal gastrectomy (rD-FLAP Study). Ann Gastroenterol Surg. 2018 Oct 11;3(1):96-103. doi: 10.1002/ags3.12216. eCollection 2019 Jan.
PubMed 30697614Aihara R, Mochiki E, Ohno T, Yanai M, Toyomasu Y, Ogata K, Ando H, Asao T, Kuwano H. Laparoscopy-assisted proximal gastrectomy with gastric tube reconstruction for early gastric cancer. Surg Endosc. 2010 Sep;24(9):2343-8. doi: 10.1007/s00464-010-0947-8. Epub 2010 Apr 8.
PubMed 20376493Tanaka K, Ebihara Y, Kurashima Y, Nakanishi Y, Asano T, Noji T, Murakami S, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Laparoscopic proximal gastrectomy with oblique jejunogastrostomy. Langenbecks Arch Surg. 2017 Sep;402(6):995-1002. doi: 10.1007/s00423-017-1587-4. Epub 2017 May 10.
PubMed 28493146Aikou T, Natsugoe S, Shimazu H, Nishi M. Antrum preserving double tract method for reconstruction following proximal gastrectomy. Jpn J Surg. 1988 Jan;18(1):114-5. doi: 10.1007/BF02470857.
PubMed 3386066Zang L. [Reconstruction following laparoscopic gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2012 Aug;15(8):787-9. Chinese.
PubMed 23072016Fujiya K, Kawamura T, Omae K, Makuuchi R, Irino T, Tokunaga M, Tanizawa Y, Bando E, Terashima M. Impact of Malnutrition After Gastrectomy for Gastric Cancer on Long-Term Survival. Ann Surg Oncol. 2018 Apr;25(4):974-983. doi: 10.1245/s10434-018-6342-8. Epub 2018 Jan 31.
PubMed 29388124Yamasaki 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 33118118Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.
PubMed 36342574GBD 2017 Stomach Cancer Collaborators. The global, regional, and national burden of stomach cancer in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):42-54. doi: 10.1016/S2468-1253(19)30328-0. Epub 2019 Oct 21.
PubMed 31648970Cui WL, Wang ZQ, Shi XL, Ma MY, Wang J, Wang ZH, Wang YP, Hong J, Hao HK. Application of Hao's Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study. BMJ Open. 2025 Aug 12;15(8):e104365. doi: 10.1136/bmjopen-2025-104365.
PubMed 40803728
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Hao's Esophagogastrostomy by Fissure Technique: a Prospective, Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06679244
- Acronym / sponsor ID
- 2024-1173
- Keywords
- proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Cancer Hospital, China
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Nov 2024 (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.
This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an innovative method named Hao's Esophagogastrostomay by Fisture Technique (HEFT).By adding anti reflux structures such as "false gastric fundus" and "false cardia" to the anastomosis of the residual stomach of the esophagus, not only can the purpose of anti reflux be achieved, but also the normal physiological channel can be maintained, it can fully utilize residual stomach function and reduce the difficulty of surgery.Through retrospective research, our single center has confirmed that HEFT is safe and feasible.On this basis, this study will compare the nutritional status, short- and medium- to long-term safety after laparoscopic HEFT and double-tract reconstruction , in order to evaluate and discover more reasonable digestive tract reconstruction methods after proximal gastrectomy, and to promote the development and popularization of minimally treatment technology for gastric cancer.
This study was jointly conducted by Shanghai-level hospitals (Huashan Hospital ,Shanghai Cancer Center, and Ruijin Hospital), with Huashan Hospital as the leading unit. This study will recruit 52 patients, with 26 patients in the experimental group and 26 patients in the control group. Using a central dynamic randomization method based on minimization, patients are assigned to groups in a 1:1 ratio. Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group).Plan to collect cases for 2 years, and follow up for another year after the last case is enrolled.
The primary endpoint of the study was the body weight loss (BWL) rate at 1 year after surgery. Secondary endpoints: Effect evaluation indicators: hemoglobin level at 1 year after surgery; Serum albumin level at 1 year after surgery; The incidence of anastomotic stenosis 1 year after surgery; Incidence of reflux esophagitis at 1 year after surgery. Evaluation of short-term surgical safety (duration: 7 days): operation time, intraoperative bleeding, anastomotic leakage, pancreatic leakage, and incidence of abdominal infection; Evaluation of medium- and long-term safety after surgery (duration: 36 months): overall survival rate at 3 years after surgery; disease-free survival rate at 3 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group). HEFT group:Patients included in this group will receive totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique(HEFT)，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer. double-tract reconstruction group:Patients included in this group will receive totally laparoscopic proximal gastrectomy with double-tract reconstruction group，which is a widely used and proven safe and effective surgical approach in proximal gastrectomy
| Arm | Type | Receives |
|---|---|---|
| Performing Hao's esophagogastrostomy by fissure technique | Experimental | Procedure: Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique |
| Performing double-tract reconstruction | Active comparator | Procedure: Totally laparoscopic proximal gastrectomy with double-tract reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years old ≤ 80 years old;
- The primary tumor lesion is located in the upper part of the stomach or the esophagogastric junction (Siewert II or III), and it is expected that R0 surgical results can be obtained by performing proximal gastrectomy and D2 dissection；
- The primary lesion was diagnosed as adenocarcinoma through endoscopic biopsy and histopathological examination;
- If it is upper gastric adenocarcinoma, the clinical TNM staging based on imaging needs to be cT1N0M0. If it is ductal gastric junction adenocarcinoma, it needs to be cT1-3N0-1M0, and clinical imaging judgment shows no distant gastric lymph node metastasis；
- Expected survival exceeds 6 months;
Key exclusion criteria (12 listed)
- Preoperative imaging examination suggests the fusion of enlarged lymph nodes (maximum diameter ≥ 3cm) in the area;
- Pregnant and lactating women;
- Suffering from other malignant tumors within 5 years;
- Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
- Serious mental illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure techniqueThis is an innovative surgical method applied in proximal gastrectomy. By adding anti reflux structures such as "false gastric fundus" and "false cardia" on the basis of esophageal residual gastric anastomosis, the goal of anti reflux is achieved, while maintaining normal physiological channels and fully utilizing residual gastric function, reducing the difficulty of proximal gastrectomy surgery | Procedure or surgery | Performing Hao's esophagogastrostomy by fissure technique |
| Totally laparoscopic proximal gastrectomy with double-tract reconstructionThis is a traditional surgical method that has been widely used in proximal gastrectomy. After disconnecting the proximal stomach, performing Roux-en-Y anastomosis of the esophagus and jejunum firstly, followed by lateral anastomosis of the residual stomach and jejunum. Previous studies have confirmed its safety and effectiveness, but there are also issues of gastric channel disuse and high missed detection rate of residual stomach. | Procedure or surgery | Performing double-tract reconstruction |
Primary outcome
body weight loss（BWL）
Time frame: From enrollment to 1 year after surgery
Measure the weight before surgery and 1 year after surgery, BWL=(preoperative weight -1 year after surgery weight)/preoperative weight (unit:%)
11 secondary outcomes
Hemoglobin 1 year after surgery
Time frame: 1 year after surgery
Serum albumin 1 year after surgery
Time frame: 1 year after surgery
Incidence of anastomotic stenosis 1 year after surgery
Time frame: 1 year after surgery
Incidence of reflux esophagitis 1 year after surgery
Time frame: 1 year after surgery
Duration of surgery
Time frame: intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Incidence of anastomotic leakage 7 days after surgery
Time frame: 7 days after surgery
Incidence of pancreatic leakage 7 days after surgery
Time frame: 7 days after surgery
Incidence of abdominal infection 7 days after surgery
Time frame: 7 days after surgery
Overall survival (OS) 3 years after surgery
Time frame: 3 years after surgery
Disease free survival (DFS) 3 years after surgery
Time frame: 3 years after surgery
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 22 Jul 2025.
- Background: PubMed 19717038Sakuramoto S, Yamashita K, Kikuchi S, Futawatari N, Katada N, Moriya H, Hirai K, Watanabe M. Clinical experience of laparoscopy-assisted proximal gastrectomy with Toupet-like partial fundoplication in early gastric cancer for preventing reflux esophagitis. J Am Coll Surg. 2009 Sep;209(3):344-51. doi: 10.1016/j.jamcollsurg.2009.04.011. Epub 2009 Jun 18.
- Background: PubMed 34240326Aizawa M, Yabusaki H, Nakada K, Matsuki A, Bamba T, Nakagawa S. A Retrospective Review of a Single-Center Experience with Posterolateral Fundoplication During Esophagogastrostomy After Proximal Gastrectomy. J Gastrointest Surg. 2021 Dec;25(12):3230-3233. doi: 10.1007/s11605-021-05052-8. Epub 2021 Jul 8. No abstract available.
- Background: PubMed 30838469Shoji Y, Nunobe S, Ida S, Kumagai K, Ohashi M, Sano T, Hiki N. Surgical outcomes and risk assessment for anastomotic complications after laparoscopic proximal gastrectomy with double-flap technique for upper-third gastric cancer. Gastric Cancer. 2019 Sep;22(5):1036-1043. doi: 10.1007/s10120-019-00940-0. Epub 2019 Mar 6.
- Background: PubMed 30697614Kuroda S, Choda Y, Otsuka S, Ueyama S, Tanaka N, Muraoka A, Hato S, Kimura T, Tanakaya K, Kikuchi S, Tanabe S, Noma K, Nishizaki M, Kagawa S, Shirakawa Y, Kamikawa Y, Fujiwara T. Multicenter retrospective study to evaluate the efficacy and safety of the double-flap technique as antireflux esophagogastrostomy after proximal gastrectomy (rD-FLAP Study). Ann Gastroenterol Surg. 2018 Oct 11;3(1):96-103. doi: 10.1002/ags3.12216. eCollection 2019 Jan.
- Background: PubMed 20376493Aihara R, Mochiki E, Ohno T, Yanai M, Toyomasu Y, Ogata K, Ando H, Asao T, Kuwano H. Laparoscopy-assisted proximal gastrectomy with gastric tube reconstruction for early gastric cancer. Surg Endosc. 2010 Sep;24(9):2343-8. doi: 10.1007/s00464-010-0947-8. Epub 2010 Apr 8.
- Background: PubMed 28493146Tanaka K, Ebihara Y, Kurashima Y, Nakanishi Y, Asano T, Noji T, Murakami S, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Laparoscopic proximal gastrectomy with oblique jejunogastrostomy. Langenbecks Arch Surg. 2017 Sep;402(6):995-1002. doi: 10.1007/s00423-017-1587-4. Epub 2017 May 10.
- Background: PubMed 3386066Aikou T, Natsugoe S, Shimazu H, Nishi M. Antrum preserving double tract method for reconstruction following proximal gastrectomy. Jpn J Surg. 1988 Jan;18(1):114-5. doi: 10.1007/BF02470857.
- Background: PubMed 23072016Zang L. [Reconstruction following laparoscopic gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2012 Aug;15(8):787-9. Chinese.
- Background: PubMed 29388124Fujiya K, Kawamura T, Omae K, Makuuchi R, Irino T, Tokunaga M, Tanizawa Y, Bando E, Terashima M. Impact of Malnutrition After Gastrectomy for Gastric Cancer on Long-Term Survival. Ann Surg Oncol. 2018 Apr;25(4):974-983. doi: 10.1245/s10434-018-6342-8. Epub 2018 Jan 31.
- 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.
- Background: PubMed 36342574Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.
- Background: PubMed 31648970GBD 2017 Stomach Cancer Collaborators. The global, regional, and national burden of stomach cancer in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):42-54. doi: 10.1016/S2468-1253(19)30328-0. Epub 2019 Oct 21.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique and Totally laparoscopic proximal gastrectomy with double-tract reconstruction in people with Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, run by Huashan Hospital at 3 sites 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 11 inclusion and 12 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Hankun Hao, doctor (+86 18121186328, haohankun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight loss（BWL） (time frame: From enrollment to 1 year after surgery). 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 NCT06679244, which also lists 13 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 22 Jul 2025.