Proximal Gastric AdenocarcinomaNCT05514769
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
A study testing Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty in people with Proximal Gastric Adenocarcinoma and Gastric Cancer, run by Nanchong Central Hospital at 1 site in China.
Trial summary
This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Proximal Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Reflux Disease
- What is being tested?
- Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Who cannot join
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
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
Yunhong Tian
Nanchong, Sichuan, 637000
Yunhong Tian, PHD, 13508087719, drtianyunhong@126.com
About this study
This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.
- Being tested
- Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
- Medical subject headings
- Stomach Neoplasms, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Gastrectomy Anterior Anastomosis With PyloroplastyProcedure or surgery
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure
| Study group | Role | What they receive |
|---|---|---|
| Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP) | Experimental | The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump. Receives: Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty |
| Control | Active comparator | The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump. Receives: Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophagus reflux disease apprised by ph monitoring
Ph monitoring by wireless or wire device
Measured: 6 months
Gastroesophagus reflux disease apprised by questionnaire
PGSAS-45 questionnaire is adopted.
Measured: 6 months
Secondary outcomes (2)
Surgical complications of proximal gastrectomy for gastric cancer
Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.
Measured: 1 year
Long-term outcome
Total survival time after proximal gastrectomy for gastric cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Gastric AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514769
- Sponsor's protocol ID
- 20220720
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05514769
- Acronym / sponsor ID
- 20220720
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 2022 (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 research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP) | Experimental | Procedure: Proximal Gastrectomy Anterior Anastomosis With PyloroplastyThe reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump. |
| Control | Active comparator | Procedure: Proximal Gastrectomy Anterior Anastomosis With PyloroplastyThe reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Key exclusion criteria (4 listed)
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
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 |
|---|---|---|
| Proximal Gastrectomy Anterior Anastomosis With PyloroplastyThe location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure | Procedure or surgery | Control, Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP) |
Primary outcome
Gastroesophagus reflux disease apprised by ph monitoring
Time frame: 6 months
Ph monitoring by wireless or wire device
Gastroesophagus reflux disease apprised by questionnaire
Time frame: 6 months
PGSAS-45 questionnaire is adopted.
2 secondary outcomes
Surgical complications of proximal gastrectomy for gastric cancer
Time frame: 1 year
Long-term outcome
Time frame: 5 years
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 31 Mar 2026.
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Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer
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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 Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty in people with Proximal Gastric Adenocarcinoma and Gastric Cancer, run by Nanchong Central 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 3 inclusion and 4 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 31 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophagus reflux disease apprised by ph monitoring (time frame: 6 months). The study lists 2 primary outcomes in all. 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 31 Mar 2026.