Gastric CancerTLPG-CBVPNCT07142122
Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial
A study testing Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction. and Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction. in people with Gastric Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction. and Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
- Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
- Clinical stage cT1bN0M0 without lymph node metastasis.
- BMI <30 kg/m².
- No history of upper abdominal surgery (except laparoscopic cholecystectomy).
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- No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- ECOG performance status 0-1.
- ASA class I-III.
- Adequate organ function.
- Signed informed consent.
Who cannot join
- Pregnancy or breastfeeding.
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
- Severe hepatic or renal dysfunction.
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- Unstable angina or myocardial infarction within 6 months.
- Stroke or intracranial hemorrhage within 6 months.
- Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
- Complications of gastric cancer (bleeding, perforation, obstruction).
- Participation in another clinical study within 6 months.
- R0 resection not achieved, change of procedure to total gastrectomy or PPG, combined surgery for other diseases, severe perioperative complications, emergency surgery required, patient withdrawal of consent, or protocol violation.
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
420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Fuzhou, Fujian, 350014
About this study
This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. The primary endpoint is gastric emptying half-time of solid food at 6 months after surgery. Secondary outcomes include incidence of reflux esophagitis, quality of life scores (EORTC QLQ-C30/STO22), number and positivity rate of lymph nodes retrieved, and 3-year disease-free survival. The study will provide evidence for optimizing minimally invasive surgical strategies for early upper gastric cancer.
Read the detailed description
Early gastric cancer involving the upper third of the stomach or esophagogastric junction is increasingly managed with minimally invasive surgery. The vagus nerve plays an essential role in regulating gastric motility and postoperative physiological recovery. Preservation of the hepatic branch is widely accepted, while the role of preserving the celiac branch remains controversial. This trial is designed to evaluate whether preservation of the celiac branch during TLPG improves gastric emptying and postoperative quality of life without compromising oncological safety. Eligible patients (cT1bN0M0, tumor size ≤4 cm, no prior chemotherapy/radiotherapy) will be randomized into two groups: Group A (hepatic and celiac branches preserved) and Group B (hepatic branch preserved only). Both groups undergo double-tract reconstruction. The study will enroll 76 patients (38 per group) with sufficient statistical power. Outcomes will be analyzed using standard statistical methods, and the findings are expected to provide evidence for refined vagus-nerve-preserving surgery in early gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction., Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.
- Keywords
- Esophagogastric Junction Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction.Procedure or surgery
Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via fenestration of the lesser omentum) and the celiac branch (via skeletonization of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor, preserving >50% of the residual stomach. Double-tract reconstruction was then performed: an end-to-side esophagojejunostomy was created first, followed by a side-to-side gastrojejunostomy between the residual stomach and jejunum, and finally a side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This approach achieves oncological resection while maximizing preservation of digestive physiology (gallbladder contraction, reduced dumping syndrome, and partial gastric reservoir function).
Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.Procedure or surgery
Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via lesser omentum fenestration adjacent to the liver edge), while deliberately not preserving the celiac branch (by direct transection at the root of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor with preservation of >50% gastric remnant. Double-tract reconstruction was then executed: end-to-side esophagojejunostomy (circular stapler) → side-to-side gastrojejunostomy (linear cutter) → side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This technique achieves oncological resection while utilizing the residual stomach and dual-pathway design to minimize postoperative dumping syndrome and preserve partial gastric function.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (Group A) | Experimental | Total laparoscopic proximal gastrectomy with preservation of hepatic and celiac branches of the vagus nerve. Reconstruction by double-tract anastomosis. Receives: Procedure: Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction. |
| Active Comparator Arm (Group B) | Active comparator | Procedure: Total laparoscopic proximal gastrectomy with preservation of hepatic branch but without preservation of the celiac branch of the vagus nerve. Reconstruction by double-tract anastomosis. Receives: Procedure: Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)
Measured: 6 months post-operation
Secondary outcomes (4)
Reflux Esophagitis (LA Classification)
Measured: 1,3,6,12,24 months
EORTC QLQ-C30/STO22 Scores
Measured: 1,3,6,12,24 months
Lymph Node Yield/Positivity Rate
Measured: Intraoperative
3-Year Disease-Free Survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142122
- Sponsor's protocol ID
- TLPG-CBVP
- Other IDs
- 2023-2839
- Acronym
- TLPG-CBVP
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07142122
- Acronym / sponsor ID
- TLPG-CBVP / TLPG-CBVP
- Conditions
- Gastric Cancer
- Keywords
- Esophagogastric Junction Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 26 Aug 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.
This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. The primary endpoint is gastric emptying half-time of solid food at 6 months after surgery. Secondary outcomes include incidence of reflux esophagitis, quality of life scores (EORTC QLQ-C30/STO22), number and positivity rate of lymph nodes retrieved, and 3-year disease-free survival. The study will provide evidence for optimizing minimally invasive surgical strategies for early upper gastric cancer.
Detailed description
Early gastric cancer involving the upper third of the stomach or esophagogastric junction is increasingly managed with minimally invasive surgery. The vagus nerve plays an essential role in regulating gastric motility and postoperative physiological recovery. Preservation of the hepatic branch is widely accepted, while the role of preserving the celiac branch remains controversial. This trial is designed to evaluate whether preservation of the celiac branch during TLPG improves gastric emptying and postoperative quality of life without compromising oncological safety. Eligible patients (cT1bN0M0, tumor size ≤4 cm, no prior chemotherapy/radiotherapy) will be randomized into two groups: Group A (hepatic and celiac branches preserved) and Group B (hepatic branch preserved only). Both groups undergo double-tract reconstruction. The study will enroll 76 patients (38 per group) with sufficient statistical power. Outcomes will be analyzed using standard statistical methods, and the findings are expected to provide evidence for refined vagus-nerve-preserving surgery in early gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (Group A) | Experimental | Procedure: Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction.Total laparoscopic proximal gastrectomy with preservation of hepatic and celiac branches of the vagus nerve. Reconstruction by double-tract anastomosis. |
| Active Comparator Arm (Group B) | Active comparator | Procedure: Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.Procedure: Total laparoscopic proximal gastrectomy with preservation of hepatic branch but without preservation of the celiac branch of the vagus nerve. Reconstruction by double-tract anastomosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
- Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
- Clinical stage cT1bN0M0 without lymph node metastasis.
- BMI <30 kg/m².
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding.
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
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 |
|---|---|---|
| Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction.Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via fenestration of the lesser omentum) and the celiac branch (via skeletonization of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor, preserving >50% of the residual stomach. Double-tract reconstruction was then performed: an end-to-side esophagojejunostomy was created first, followed by a side-to-side gastrojejunostomy between the residual stomach and jejunum, and finally a side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This approach achieves oncological resection while maximizing preservation of digestive physiology (gallbladder contraction, reduced dumping syndrome, and partial gastric reservoir function). | Procedure or surgery | Experimental Arm (Group A) |
| Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via lesser omentum fenestration adjacent to the liver edge), while deliberately not preserving the celiac branch (by direct transection at the root of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor with preservation of >50% gastric remnant. Double-tract reconstruction was then executed: end-to-side esophagojejunostomy (circular stapler) → side-to-side gastrojejunostomy (linear cutter) → side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This technique achieves oncological resection while utilizing the residual stomach and dual-pathway design to minimize postoperative dumping syndrome and preserve partial gastric function. | Procedure or surgery | Active Comparator Arm (Group B) |
Primary outcome
Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)
Time frame: 6 months post-operation
4 secondary outcomes
Reflux Esophagitis (LA Classification)
Time frame: 1,3,6,12,24 months
EORTC QLQ-C30/STO22 Scores
Time frame: 1,3,6,12,24 months
Lymph Node Yield/Positivity Rate
Time frame: Intraoperative
3-Year Disease-Free Survival
Time frame: 36 months
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 26 Aug 2025.
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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?
A study testing Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction. and Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction. in people with Gastric Cancer, run by Fujian Cancer Hospital 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 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 26 Aug 2025. 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 Zaisheng Ye, doctoral (+86 591 13950203076, flyingengel@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test) (time frame: 6 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2025.