Gastric CancerPhase 3NCT00529412
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction
A Phase 3 study testing Seprafilm in people with Gastric Cancer, run by Nihon University at 1 site in Japan.
Trial summary
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Seprafilm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2003to Mar 2007
- 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 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of gastric cancer
- Operable
Who cannot join
- Withdrew consent
- Pregnant
- Ascites
- Distant metastasis
- Liver dysfunction (serum total bilirubin >2.0 mg/dL)
- Renal failure (serum creatinine >1.5 mg/dL)
- A past history of small bowel obstruction.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Digestive Surgery, NIhon University School of Medicine
Tokyo, 173-8610
About this study
Official title: Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.
Read the detailed description
Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.
- Conditions
- Gastric Cancer
- Being tested
- Seprafilm
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprafilmOther
two sheets per body
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | no Seprafilm Receives: Other: Seprafilm |
| Seprafilm | Active comparator | Not described Receives: Other: Seprafilm |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of small bowel obstruction
Measured: 3 years, more than 6 months after gastrectomy
Secondary outcomes (1)
intraoperative and postoperative morbidity and mortality.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startAug 2003
- Study completionMar 2007
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Investigators
- Tadatoshi Takayama, MD, PhD, Study chair, Department of Digestive Surgery, Nihon University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529412
- Sponsor's protocol ID
- NUSM-CC-01
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2007
- Last updated
- 14 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayashi S, Takayama T, Masuda H, Kochi M, Ishii Y, Matsuda M, Yamagata M, Fujii M. Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial. Ann Surg. 2008 May;247(5):766-70. doi: 10.1097/SLA.0b013e3181656d4e.
PubMed 18438113
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00529412
- Acronym / sponsor ID
- NUSM-CC-01
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Sep 2007 (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.
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.
Detailed description
Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Other: Seprafilmno Seprafilm |
| Seprafilm | Active comparator | Other: Seprafilm |
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of gastric cancer
- Operable
Key exclusion criteria (7 listed)
- Withdrew consent
- Pregnant
- Ascites
- Distant metastasis
- Liver dysfunction (serum total bilirubin >2.0 mg/dL)
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 |
|---|---|---|
| Seprafilmtwo sheets per body | Other | Seprafilm, control |
Primary outcome
incidence of small bowel obstruction
Time frame: 3 years, more than 6 months after gastrectomy
1 secondary outcome
intraoperative and postoperative morbidity and mortality.
Time frame: 3 years
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 14 Sep 2007.
- Derived from this study: PubMed 18438113Hayashi S, Takayama T, Masuda H, Kochi M, Ishii Y, Matsuda M, Yamagata M, Fujii M. Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial. Ann Surg. 2008 May;247(5):766-70. doi: 10.1097/SLA.0b013e3181656d4e.
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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.
Tadatoshi Takayama, MD, PhD study chair
Department of Digestive Surgery, Nihon University School of Medicine
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 Seprafilm in people with Gastric Cancer, run by Nihon 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 2 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: finished, as of the sponsor's last update on 14 Sep 2007. 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?
incidence of small bowel obstruction (time frame: 3 years, more than 6 months after gastrectomy). 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 NCT00529412, 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 14 Sep 2007.