Stomach NeoplasmsNCT05890339
Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer
A study testing Laparoscopic Proximal Gastrectomy With Double-flap Technique and Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction 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. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, which seriously affects the quality of life, and the short-term outcome is poorer than the… 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?
- Laparoscopic Proximal Gastrectomy With Double-flap Technique and Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 10 May 2033
- 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(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
- scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total 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 laparoscopic surgery.
- The patients have signed the informed consent form.
Who cannot join
- history of upper abdominal surgery (except laparoscopic cholecystectomy);
- 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
- require simultaneous surgery due to complicated with other diseases
- 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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
About this study
Official title: Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer: a Multi-center Randomized Controlled Trial
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, 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 status than total gastrectomy.
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach, which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the occurrence of reflux oesophagitis. At present, the studies for double-flap technique in China and other countries are mostly retrospective studies, and there are short of large-scale prospective studies and evidence of evidence-based medicine.
The applicant has initiated a phase II, single center, single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer. To further validate the short and long-term outcomes of this procedure, a multicentre, open label, prospective, superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include 216 patients with proximal early gastric cancer. The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The short and long-term oncological outcomes are also explored. This trial can provide high-grade evidence of evidence-based medicine for double-flap technique's clinical applications .
- Conditions
- Stomach Neoplasms
- Being tested
- Laparoscopic Proximal Gastrectomy With Double-flap Technique, Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
- Keywords
- laparoscopy, 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.
Laparoscopic Proximal Gastrectomy With Double-flap TechniqueProcedure or surgery
Patients in this group receive laparoscopic 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 esophagogastric reconstruction.
Laparoscopic Total Gastrectomy With Roux-en-Y ReconstructionProcedure or surgery
Patients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p；D2 for stage IB: Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is used for the esophagojejunal reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Proximal Gastrectomy With Double-flap Technique | Experimental | Not described Receives: Procedure: Laparoscopic Proximal Gastrectomy With Double-flap Technique |
| Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction | Active comparator | Not described Receives: Procedure: Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction |
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 are graded according to the Los Angeles (LA) classification.
Measured: 12 months postoperatively
Secondary outcomes (30)
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 hemoglobin levels at Follow-up
blood hemoglobin(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in Vitamin B12 levels at Follow-up
blood Vitamin B12（μg/ml) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in total protein levels 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 levels at Follow-up
blood serum albumin(g/L) levels
Measured: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin levels at Follow-up
blood prealbumin(g/L) 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(ml) during surgery
Measured: 24 hours postoperatively
3-year disease-free survival rate
3-year disease-free survival rate
Measured: 3 years
3-year overall survival rate
3-year overall survival rate
Measured: 3 years
3-year recurrence pattern
3-year recurrence pattern
Measured: 3 years
5-year disease-free survival rate
5-year disease-free survival rate
Measured: 5 years
5-year overall survival rate
5-year overall survival rate
Measured: 5 years
5-year recurrence pattern
5-year recurrence pattern
Measured: 5 years
body mass index postoperatively
body mass index(kg/m^2)
Measured: Follow-up evaluations are performed 3, 6 and 12 months 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
Postoperative pain assessment
We measured the pain score using visual analog scale(VAS) at 24 hours after the surgery is completed. Higher scores mean a worse outcome.
Measured: Day 1 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
Pathological Characteristics
R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.
Measured: 1 week 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 posted6 Jun 2023
- Study start10 Jun 2023 (estimated)
- Primary completion10 Dec 2029 (estimated)
- Study completion10 May 2033 (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.
- 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
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Tianjin Medical University Cancer Institute and Hospital, Liaoning Cancer Hospital & Institute, Sichuan Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Qilu Hospital of Shandong University, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, Zunyi Medical College, Sichuan Cancer Hospital and Research Institute, Gansu Provincial Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Qinghai Province Fifth People's Hospital, LanZhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890339
- Sponsor's protocol ID
- SYSKY-2022-276-02
- Status last verified
- Sep 2022
- First submitted
- 3 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou S, Xie Y, Zhu Y, Tan J, Yang B, Zhong L, Zhong G, Han F. Comparing the antireflux effect of laparoscopic proximal gastrectomy with double-flap technique reconstruction versus laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer: study protocol for a multicentre, prospective, open-label, randomised controlled trial. BMJ Open. 2024 Jul 4;14(7):e079940. doi: 10.1136/bmjopen-2023-079940.
PubMed 38964794
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05890339
- Acronym / sponsor ID
- SYSKY-2022-276-02
- Conditions
- Stomach Neoplasms
- Keywords
- laparoscopy, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Tianjin Medical University Cancer Institute and Hospital, Liaoning Cancer Hospital & Institute, Sichuan Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Qilu Hospital of Shandong University, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, Zunyi Medical College, Sichuan Cancer Hospital and Research Institute, Gansu Provincial Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Qinghai Province Fifth People's Hospital, LanZhou University
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 10 Dec 2029 (estimated)
- Study completion
- 10 May 2033 (estimated)
- First posted
- 6 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. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, 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 status than total gastrectomy.
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach, which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the occurrence of reflux oesophagitis. At present, the studies for double-flap technique in China and other countries are mostly retrospective studies, and there are short of large-scale prospective studies and evidence of evidence-based medicine.
The applicant has initiated a phase II, single center, single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer. To further validate the short and long-term outcomes of this procedure, a multicentre, open label, prospective, superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include 216 patients with proximal early gastric cancer. The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The short and long-term oncological outcomes are also explored. This trial can provide high-grade evidence of evidence-based medicine for double-flap technique's clinical applications .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Proximal Gastrectomy With Double-flap Technique | Experimental | Procedure: Laparoscopic Proximal Gastrectomy With Double-flap Technique |
| Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction | Active comparator | Procedure: Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
- scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total 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 (except laparoscopic cholecystectomy);
- 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
- require simultaneous surgery due to complicated with other diseases
- 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 |
|---|---|---|
| Laparoscopic Proximal Gastrectomy With Double-flap TechniquePatients in this group receive laparoscopic 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 esophagogastric reconstruction. | Procedure or surgery | Laparoscopic Proximal Gastrectomy With Double-flap Technique |
| Laparoscopic Total Gastrectomy With Roux-en-Y ReconstructionPatients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p；D2 for stage IB: Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is used for the esophagojejunal reconstruction. | Procedure or surgery | Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction |
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 are graded according to the Los Angeles (LA) classification.
30 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 hemoglobin levels at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in Vitamin B12 levels at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in total protein levels at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in serum albumin levels at Follow-up
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin levels 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
3-year disease-free survival rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
3-year recurrence pattern
Time frame: 3 years
5-year disease-free survival rate
Time frame: 5 years
5-year overall survival rate
Time frame: 5 years
5-year recurrence pattern
Time frame: 5 years
body mass index postoperatively
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Quality of Life postoperatively
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Postoperative pain assessment
Time frame: Day 1 postoperatively
Pathological Characteristics
Time frame: 1 week postoperatively
Pathological Characteristics
Time frame: 1 week postoperatively
Pathological Characteristics
Time frame: 1 week 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 6 Jun 2023.
- Derived from this study: PubMed 38964794Zhou S, Xie Y, Zhu Y, Tan J, Yang B, Zhong L, Zhong G, Han F. Comparing the antireflux effect of laparoscopic proximal gastrectomy with double-flap technique reconstruction versus laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer: study protocol for a multicentre, prospective, open-label, randomised controlled trial. BMJ Open. 2024 Jul 4;14(7):e079940. doi: 10.1136/bmjopen-2023-079940.
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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 Laparoscopic Proximal Gastrectomy With Double-flap Technique and Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction 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 7 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: opening soon, as of the sponsor's last update on 6 Jun 2023. 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 Han Fanhai, Professor (+86-135-8031-7677, fh_han@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 NCT05890339, 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 6 Jun 2023.