Stomach NeoplasmsNCT05892289
Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer
A study testing Robotic assisted proximal gastrectomy with double-flap technique in people with Stomach Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Robotic assisted proximal gastrectomy with double-flap technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to 10 Dec 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years ≤ age ≤ 80 years
- The primary gastric lesions were located in the proximal third of the stomach
- histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
- scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
- The preoperative American Society of Anesthesiologists (ASA) physical status was I-III;
- The patient's cardiopulmonary function can tolerate robotic assisted surgery;
- The subjects have signed the informed consent form.
Who cannot join
- history of upper abdominal surgery and not suitable for robotic assisted surgery
- the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
- with other malignant diseases or have suffered from other malignant diseases within 5 years
- Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure
- women are pregnant or in lactation period
- Suffering from serious mental illness
- history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month
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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Yang bin, 13798163278, yyzsu@163.com
About this study
Official title: Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.
Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..
- Conditions
- Stomach Neoplasms
- Being tested
- Robotic assisted proximal gastrectomy with double-flap technique
- Keywords
- Robotic Surgical Procedures, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis
- Medical subject headings
- Stomach Neoplasms, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted proximal gastrectomy with double-flap techniqueProcedure or surgery
Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted proximal gastrectomy with double-flap technique | Experimental | Not described Receives: Procedure: Robotic assisted proximal gastrectomy with double-flap technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.
Measured: 12 months postoperatively
Secondary outcomes (24)
Quality of Life after Surgery
Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) 30-item core QoL (QLQ-C30 ver.3.0). Higher scores mean a worse outcome.
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Gastrointestinal Symptoms after Surgery
gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Changes in total protein at Follow-up
blood total protein(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in serum albumin at Follow-up
blood serum albumin(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin at Follow-up
blood prealbumin(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in hemoglobin at Follow-up
blood hemoglobin(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in Vitamin B12 at Follow-up
blood Vitamin B12(μg/ml) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Late Postoperative Morbidity
adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Early Postoperative Morbidity
operation wound with seroma, hematoma, infection, dehiscence, or evisceration, anastomotic leakage, anastomotic bleeding, abdominal bleeding, abdominal abscess, intestinal obstruction morbidity, gastrointestinal bleeding, gastroparesis, postoperative pancreatitis, pancreatic fistula, chylous leakage, lung morbidity, cerebrovascular morbidity, cardiovascular morbidity, deep vein thrombosis, cholecystitis, liver dysfunction, kidney dysfunction. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.
Measured: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to pass gas(hours)
Measured: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to oral intake(hours)
Measured: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to indwell gastric tube(hours)
Measured: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
length of postoperative hospitalisation(days)
Measured: From surgery to discharge, up to 30 days
Surgical Characteristics
operative time(minutes)
Measured: 24 hours postoperatively
Surgical Characteristics
time for reconstruction the digestive tract(minutes) during surgery
Measured: 24 hours postoperatively
Surgical Characteristics
blood loss during surgery(ml)
Measured: 24 hours postoperatively
Quality of Life postoperatively
Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) gastric cancer module (QLQ-STO22) questionnaire. Higher scores mean a worse outcome.
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Pathological Characteristics
R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.
Measured: 1 week postoperatively
Pathological Characteristics
lymph nodes dissection extent for each patient in the surgery
Measured: 1 week postoperatively
Pathological Characteristics
number of dissected lymph nodes for each patient in the surgery
Measured: 1 week postoperatively
body mass index postoperatively
body mass index(kg/m^2)
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
pain assessment postoperatively
We measured the pain score using visual analog scale(VAS) at 24 h after the surgery is completed. Higher scores mean a worse outcome.
Measured: Day 1 postoperatively
Proportion of participants die after surgery
mortality rate
Measured: From surgery to discharge, up to 30 days
Proportion of participants need to rehospitalized after surgery
rehospitalization rate
Measured: From surgery to discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start10 Jun 2024
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Kunming Medical University, First Hospital of China Medical University, Gansu Provincial Hospital, Qilu Hospital of Shandong University, Shandong Provincial Hospital, Sichuan Cancer Hospital and Research Institute, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, LanZhou University, Third Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University Cancer Institute and Hospital, Zunyi Medical College, Liaoning Cancer Hospital & Institute, Qinghai Province Fifth People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892289
- Sponsor's protocol ID
- SYSKY-2022-275-02
- Status last verified
- May 2025
- First submitted
- 4 May 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated and/or analysed during the current study are not publicly available due to governmental policy regarding individual information. However, they are available from the Sun Yat-Sen Memorial Hospital data center upon reasonable request, subject to approval by the Sun Yat-Sen Memorial Hospital Ethics Committee and the Data and Safety Monitoring Committee. This will be after the publication of the main findings, in line with standard data-sharing practices for clinical trial data sets. The Sun Yat-Sen Memorial Hospital data center will ensure the confidentiality of all participants' data and will not disclose information by which participants may be identified to any third party other than those directly involved in the treatment of the participant and organisations for which the participant has provided explicit consent for data transfer.
Publications
Zhong G, Xie Y, Chen G, Zhu Y, Yang B, Tan J, Han F, Zhou S. Assessing the feasibility and safety of robotic-assisted proximal gastrectomy with double-flap technique for proximal early gastric cancer: study protocol for a phase II, multicentre, single-arm clinical trial. BMJ Open. 2025 Aug 10;15(8):e094661. doi: 10.1136/bmjopen-2024-094661.
PubMed 40789587
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT05892289
- Acronym / sponsor ID
- SYSKY-2022-275-02
- Conditions
- Stomach Neoplasms
- Keywords
- Robotic Surgical Procedures, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Kunming Medical University, First Hospital of China Medical University, Gansu Provincial Hospital, Qilu Hospital of Shandong University, Shandong Provincial Hospital, Sichuan Cancer Hospital and Research Institute, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, LanZhou University, Third Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University Cancer Institute and Hospital, Zunyi Medical College, Liaoning Cancer Hospital & Institute, Qinghai Province Fifth People's Hospital
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 7 Jun 2023 (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.
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.
Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted proximal gastrectomy with double-flap technique | Experimental | Procedure: Robotic assisted proximal gastrectomy with double-flap technique |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 20 years ≤ age ≤ 80 years
- The primary gastric lesions were located in the proximal third of the stomach
- histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
- scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
Key exclusion criteria (7 listed)
- history of upper abdominal surgery and not suitable for robotic assisted surgery
- the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
- with other malignant diseases or have suffered from other malignant diseases within 5 years
- Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure
- women are pregnant or in lactation period
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 |
|---|---|---|
| Robotic assisted proximal gastrectomy with double-flap techniquePatients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction. | Procedure or surgery | Robotic assisted proximal gastrectomy with double-flap technique |
Primary outcome
The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
Time frame: 12 months postoperatively
During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.
24 secondary outcomes
Quality of Life after Surgery
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Gastrointestinal Symptoms after Surgery
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Changes in total protein at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in serum albumin at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in hemoglobin at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in Vitamin B12 at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Late Postoperative Morbidity
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Early Postoperative Morbidity
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
Time frame: From surgery to discharge, up to 30 days
Surgical Characteristics
Time frame: 24 hours postoperatively
Surgical Characteristics
Time frame: 24 hours postoperatively
Surgical Characteristics
Time frame: 24 hours postoperatively
Quality of Life postoperatively
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Pathological Characteristics
Time frame: 1 week postoperatively
Pathological Characteristics
Time frame: 1 week postoperatively
Pathological Characteristics
Time frame: 1 week postoperatively
body mass index postoperatively
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
pain assessment postoperatively
Time frame: Day 1 postoperatively
Proportion of participants die after surgery
Time frame: From surgery to discharge, up to 30 days
Proportion of participants need to rehospitalized after surgery
Time frame: From surgery to discharge, up to 30 days
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 25 May 2025.
- Derived from this study: PubMed 40789587Zhong G, Xie Y, Chen G, Zhu Y, Yang B, Tan J, Han F, Zhou S. Assessing the feasibility and safety of robotic-assisted proximal gastrectomy with double-flap technique for proximal early gastric cancer: study protocol for a phase II, multicentre, single-arm clinical trial. BMJ Open. 2025 Aug 10;15(8):e094661. doi: 10.1136/bmjopen-2024-094661.
- Individual participant dataSharing planned: Yes. The data sets generated and/or analysed during the current study are not publicly available due to governmental policy regarding individual information. However, they are available from the Sun Yat-Sen Memorial Hospital data center upon reasonable request, subject to approval by the Sun Yat-Sen Memorial Hospital Ethics Committee and the Data and Safety Monitoring Committee. This will be after the publication of the main findings, in line with standard data-sharing practices for clinical trial data sets. The Sun Yat-Sen Memorial Hospital data center will ensure the confidentiality of all participants' data and will not disclose information by which participants may be identified to any third party other than those directly involved in the treatment of the participant and organisations for which the participant has provided explicit consent for data transfer.
Related trials for Stomach Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 Robotic assisted proximal gastrectomy with double-flap technique in people with Stomach Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 7 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 25 May 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 Yang bin, associate professor (13798163278, yyzsu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively (time frame: 12 months 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 NCT05892289, which also lists 1 linked publication.
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 25 May 2025.