Gastric CancerPhase 1NCT00677456
Evaluation of Four Reconstructions After Total Gastrectomy
A Phase 1 study testing R-Y reconstruction after total gastrectomy, P-Y reconstruction after total gastrectomy and Pouch reconstruction after total gastrectomy in people with Gastric Cancer and Nutrition, run by Tang-Du Hospital at 1 site in China.
Trial summary
There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Gastric Cancer, Nutrition
- What is being tested?
- R-Y reconstruction after total gastrectomy, P-Y reconstruction after total gastrectomy and Pouch reconstruction after total gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jan 2013
- Phase
- Phase 1
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.
Who cannot join
- death or other reason which cause information discontinue
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of general surgery,Tangdu hospital
Xi'an, Shaanxi, 710038
GuoQiang Bao, doctor, 86-029-8477-7731, guoqiangbao@163.com
JiKai Yin, doctor, 86-029-8477-7732, yjkfmmuu@hotmail.com
About this study
Official title: Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.
- Conditions
- Gastric Cancer, Nutrition
- Being tested
- R-Y reconstruction after total gastrectomy, P-Y reconstruction after total gastrectomy, Pouch reconstruction after total gastrectomy, P-I reconstruction after total gastrectomy
- Keywords
- Gastric Cancer, total gastrectomy, reconstruction, life quality
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Y reconstruction after total gastrectomyProcedure or surgery
Also called R-Y reconstruction
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
P-Y reconstruction after total gastrectomyProcedure or surgery
Also called P-Y reconstruction
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.
Pouch reconstruction after total gastrectomyProcedure or surgery
Also called Pouch reconstruction
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
P-I reconstruction after total gastrectomyProcedure or surgery
Also called P-I reconstruction
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will receive R-Y reconstruction after total gastrectomy as intervention Receives: Procedure: R-Y reconstruction after total gastrectomy |
| 2 | Active comparator | Patients will receive P-Y reconstruction after total gastrectomy as intervention Receives: Procedure: P-Y reconstruction after total gastrectomy |
| 3 | Active comparator | Patients will receive Pouch reconstruction after total gastrectomy as intervention. Receives: Procedure: Pouch reconstruction after total gastrectomy |
| 4 | Active comparator | Patients will receive P-I reconstruction after total gastrectomy as intervention. Receives: Procedure: P-I reconstruction after total gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients should live for 6 months at least, and with acceptable life quality
Measured: 6 months
Secondary outcomes (1)
There are significant differences among life qualities of the four reconstructions
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 posted14 May 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2010 (estimated)
- Study completionJan 2013 (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 Tang-Du 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Investigators
- XianLi He, doctor, Principal investigator, Department of general surgery, Tangdu hospital of fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677456
- Sponsor's protocol ID
- TDH00431
- Status last verified
- Jan 2008
- First submitted
- 12 May 2008
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
- ClinicalTrials.gov ID
- NCT00677456
- Acronym / sponsor ID
- TDH00431
- Conditions
- Gastric Cancer, Nutrition
- Keywords
- Gastric Cancer, total gastrectomy, reconstruction, life quality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 14 May 2008 (estimated)
- 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.
There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: R-Y reconstruction after total gastrectomyPatients will receive R-Y reconstruction after total gastrectomy as intervention |
| 2 | Active comparator | Procedure: P-Y reconstruction after total gastrectomyPatients will receive P-Y reconstruction after total gastrectomy as intervention |
| 3 | Active comparator | Procedure: Pouch reconstruction after total gastrectomyPatients will receive Pouch reconstruction after total gastrectomy as intervention. |
| 4 | Active comparator | Procedure: P-I reconstruction after total gastrectomyPatients will receive P-I reconstruction after total gastrectomy as intervention. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.
Key exclusion criteria (1 listed)
- death or other reason which cause information discontinue
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 |
|---|---|---|
| R-Y reconstruction after total gastrectomyAlso: R-Y reconstructionFollowing curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y. | Procedure or surgery | 1 |
| P-Y reconstruction after total gastrectomyAlso: P-Y reconstructionFollowing curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y. | Procedure or surgery | 2 |
| Pouch reconstruction after total gastrectomyAlso: Pouch reconstructionFollowing curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y. | Procedure or surgery | 3 |
| P-I reconstruction after total gastrectomyAlso: P-I reconstructionFollowing curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I. | Procedure or surgery | 4 |
Primary outcome
Patients should live for 6 months at least, and with acceptable life quality
Time frame: 6 months
1 secondary outcome
There are significant differences among life qualities of the four reconstructions
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 14 May 2008.
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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.
XianLi He, doctor principal investigator
Department of general surgery, Tangdu hospital of fourth military medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-Y reconstruction after total gastrectomy, P-Y reconstruction after total gastrectomy and Pouch reconstruction after total gastrectomy in people with Gastric Cancer and Nutrition, run by Tang-Du 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 1 inclusion and 1 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 14 May 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xian Li He, doctor (86-029-8477-7432, wanghe@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients should live for 6 months at least, and with acceptable life quality (time frame: 6 months). 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 14 May 2008.