Pancreatic CancerNCT00906802
Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy
A study testing R-Y reconstruction in people with Pancreatic Cancer, run by Kochi University at 1 site in Japan.
Trial summary
One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- R-Y reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2003to Apr 2010
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass
Who cannot join
- A body weight loss greater than 10% during the six months prior to surgery
- The presence of distant metastases
- Seriously impaired function of vital organs due to respiratory, renal or heart disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kochi Medical School
Nankoku, Kochi, 783-8505
Takehiro Okabayashi, MD, PhD, 81-88-880-2370, tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof, 81-88-880-2370, im31@kochi-u.ac.jp
About this study
Official title: Benefit of R-Y Reconstruction After Pancreaticoduodenectomy
One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.
Read the detailed description
We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.
- Conditions
- Pancreatic Cancer
- Being tested
- R-Y reconstruction
- Keywords
- pancreaticoduodenectomy, reconstruction
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Y reconstructionProcedure or surgery
Also called the cutting R-Y anastmosis
The reconstruction was performed by R-Y anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| R-Y reconstruction | Experimental | the reconstruction was performed by R-Y anastomosis Receives: Procedure: R-Y reconstruction |
| conventional reconstruction | No intervention | the anastomosis was performed by B-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of DGE
Measured: 3-6 months
Secondary outcomes (1)
the incidence of other complication associated with reconstruction
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2003
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Investigators
- Kazuhiro Hanazaki, Prof, Study chair, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906802
- Sponsor's protocol ID
- RPD Study
- Status last verified
- Jul 2009
- First submitted
- 19 May 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of R-Y Reconstruction After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT00906802
- Acronym / sponsor ID
- RPD Study
- Conditions
- Pancreatic Cancer
- Keywords
- pancreaticoduodenectomy, reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 21 May 2009 (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.
One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.
Detailed description
We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-Y reconstruction | Experimental | Procedure: R-Y reconstructionthe reconstruction was performed by R-Y anastomosis |
| conventional reconstruction | No intervention | –the anastomosis was performed by B-II |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass
Key exclusion criteria (3 listed)
- A body weight loss greater than 10% during the six months prior to surgery
- The presence of distant metastases
- Seriously impaired function of vital organs due to respiratory, renal or heart disease
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 reconstructionAlso: the cutting R-Y anastmosisThe reconstruction was performed by R-Y anastomosis. | Procedure or surgery | R-Y reconstruction |
Primary outcome
the incidence of DGE
Time frame: 3-6 months
1 secondary outcome
the incidence of other complication associated with reconstruction
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
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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.
Kazuhiro Hanazaki, Prof study chair
Kochi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R-Y reconstruction in people with Pancreatic Cancer, run by Kochi 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 1 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 23 Jul 2009. 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.
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 Takehiro Okabayashi, MD, PhD (81-88-880-2370, tokabaya@kochi-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of DGE (time frame: 3-6 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 23 Jul 2009.