Gastric CancerNCT06354036
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy
A study testing the Transhiatal Tunnel Valvuloplasty technique in people with Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method. Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- the Transhiatal Tunnel Valvuloplasty technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Confirmed by gastroscopy pathological biopsy and imaging examination as early adenocarcinoma of the upper part of the stomach or adenocarcinoma of the esophageal gastric junction;
- Tumor diameter<4cm, with no distant metastasis;
- Clinical staging T1-3N0-1M0;
- On the basis of proximal gastrectomy, 50% of the gastric volume can still be retained;
- ECOG-PS status score 0-1 points (Eastern Cooperative Oncology Group).
Who cannot join
- Patients undergoing preoperative neoadjuvant chemotherapy;
- Patients with severe cardiovascular and pulmonary diseases who cannot tolerate laparoscopic surgery;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Dongbing R Zhao, M.D., +86-13901331816, dbzhao2003@sina.com
About this study
Official title: Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy，Phase II Trial
Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.
Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.
Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis.
- Conditions
- Gastric Cancer
- Being tested
- the Transhiatal Tunnel Valvuloplasty technique
- Keywords
- Proximal gastrectomy, Valvulopathy
- Medical subject headings
- Stomach Neoplasms, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Transhiatal Tunnel Valvuloplasty techniqueProcedure or surgery
The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| ThTV（the Transhiatal Tunnel Valvuloplasty technique group） | Experimental | Patients who meet the inclusion criteria will undergo ThTV anastomosis after proximal gastrectomy Receives: Procedure: the Transhiatal Tunnel Valvuloplasty technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative reflux esophagitis
postoperative reflux
Measured: 1 year
Secondary outcomes (2)
the incidence of postoperative anastomotic fistula
Postoperative anastomotic fistula
Measured: 1 year
the incidence of anastomotic stenosis
postoperative anastomotic stenosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Bing Zhao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354036
- Sponsor's protocol ID
- NCC4465
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy，Phase II Trial
- ClinicalTrials.gov ID
- NCT06354036
- Acronym / sponsor ID
- NCC4465
- Conditions
- Gastric Cancer
- Keywords
- Proximal gastrectomy, Valvulopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Apr 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.
Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.
Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.
Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThTV（the Transhiatal Tunnel Valvuloplasty technique group） | Experimental | Procedure: the Transhiatal Tunnel Valvuloplasty techniquePatients who meet the inclusion criteria will undergo ThTV anastomosis after proximal gastrectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed by gastroscopy pathological biopsy and imaging examination as early adenocarcinoma of the upper part of the stomach or adenocarcinoma of the esophageal gastric junction;
- Tumor diameter<4cm, with no distant metastasis;
- Clinical staging T1-3N0-1M0;
- On the basis of proximal gastrectomy, 50% of the gastric volume can still be retained;
- ECOG-PS status score 0-1 points (Eastern Cooperative Oncology Group).
Key exclusion criteria (3 listed)
- Patients undergoing preoperative neoadjuvant chemotherapy;
- Patients with severe cardiovascular and pulmonary diseases who cannot tolerate laparoscopic surgery;
- Incomplete clinical data.
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 |
|---|---|---|
| the Transhiatal Tunnel Valvuloplasty techniqueThe ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus. | Procedure or surgery | ThTV（the Transhiatal Tunnel Valvuloplasty technique group） |
Primary outcome
The incidence of postoperative reflux esophagitis
Time frame: 1 year
postoperative reflux
2 secondary outcomes
the incidence of postoperative anastomotic fistula
Time frame: 1 year
the incidence of anastomotic stenosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Transhiatal Tunnel Valvuloplasty technique in people with Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongbing Zhao (87787121, dbzhao@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative reflux esophagitis (time frame: 1 year). 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 10 Apr 2024.