Gastric CancerPhase 3NCT00746161
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
A Phase 3 study testing Reconstruction after total gastrectomy in people with Gastric Cancer, run by Wakayama Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Reconstruction after total gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2002to Apr 2008
- Phase
- Phase 3
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
- Age 80 years or younger
- No distant metastasis
Who cannot join
- Carcinoma in the remnant stomach
- Stage intravenous (IV)
- History of laparotomy
- History of serious heart disease
- Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
Japan1 site
Second Department of Surgery, Wakayama Medical University
Wakayama, Wakayama, 641-8510
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method
Read the detailed description
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Reconstruction after total gastrectomy
- Keywords
- total gastrectomy, double tract reconstruction, gastric cancer, Total gastrectomy in patients with gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction after total gastrectomyProcedure or surgery
Roux-en-Y
Reconstruction after total gastrectomyProcedure or surgery
double tract reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Roux-en-Y Receives: Procedure: Reconstruction after total gastrectomy |
| 2 | Experimental | double tract reconstruction Receives: Procedure: Reconstruction after total gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The %body weight ratio
Measured: 12 months after operation
Secondary outcomes (1)
preoperative complication, PNI and QOL score
Measured: within one month, and 3 and 12months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startApr 2002
- Primary completionJan 2008
- Study completionApr 2008
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 Gastric CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Makoto Iwahashi, Principal investigator, Second Department of Surgery, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746161
- Sponsor's protocol ID
- WMU-GC02
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
PubMed 19548028
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT00746161
- Acronym / sponsor ID
- WMU-GC02
- Conditions
- Gastric Cancer
- Keywords
- total gastrectomy, double tract reconstruction, gastric cancer, Total gastrectomy in patients with gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Sep 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.
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method
Detailed description
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Reconstruction after total gastrectomyRoux-en-Y |
| 2 | Experimental | Procedure: Reconstruction after total gastrectomydouble tract reconstruction |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
- Age 80 years or younger
- No distant metastasis
Key exclusion criteria (6 listed)
- Carcinoma in the remnant stomach
- Stage intravenous (IV)
- History of laparotomy
- History of serious heart disease
- Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
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 |
|---|---|---|
| Reconstruction after total gastrectomyRoux-en-Y | Procedure or surgery | 1 |
| Reconstruction after total gastrectomydouble tract reconstruction | Procedure or surgery | 2 |
Primary outcome
The %body weight ratio
Time frame: 12 months after operation
1 secondary outcome
preoperative complication, PNI and QOL score
Time frame: within one month, and 3 and 12months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2008.
- Derived from this study: PubMed 19548028Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
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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.
Makoto Iwahashi principal investigator
Second Department of Surgery, Wakayama 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 3 study testing Reconstruction after total gastrectomy in people with Gastric Cancer, run by Wakayama Medical University at 1 site in Japan.
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 6 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: finished, as of the sponsor's last update on 4 Sep 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The %body weight ratio (time frame: 12 months after operation). 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 NCT00746161, 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 4 Sep 2008.