Pancreatic NeoplasmsPhase 2NCT02270554
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy
A Phase 2 study testing Endo GIA Reinforced Reload with Tri-Staple technology in people with Pancreatic Neoplasms, run by Wakayama Medical University at 11 sites in Japan.
Trial summary
The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Endo GIA Reinforced Reload with Tri-Staple technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesJapan
- Study dates
- Oct 2014to Jul 2016
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- disease of pancreatic body and tail
- PS (ECOG Performance Status Scale)0-1
- Age: 20 years or older
- distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
- Patients who can provide written informed consent
Who cannot join
- Patients with severe ischemic cardiac disease
- Patients with severe liver cirrhosis or active hepatitis
- Patients with respiratory illness that requires oxygen administration
- Patients with chronic renal failure requiring dialysis
- Patients requiring other organ resection
- Patients who are unfit for the study as determined by the attending physician
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Kansai Rosai Hospital
Amagasaki, Hyogo
Kansai Medical University
Hirakata, Osaka
Hiroshima University
Hiroshima, Hiroshima
Nara Medical University
Kashihara, Nara
Kobe University
Kobe, Hyogo
Kyoto Prefectural University of Medicine
Kyoto
Nagoya University
Nagoya, Aichi
Hyogo College of Medicine
Nishinomiya, Hyogo
Osaka University
Osaka
Kinki University
Sayama, Osaka
Wakayama Medical University
Wakayama, 641-8510
About this study
Official title: A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
Read the detailed description
Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Endo GIA Reinforced Reload with Tri-Staple technology
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo GIA Reinforced Reload with Tri-Staple technologyDevice
Device:Endo GIA Reinforced Reload with Tri-Staple technology
| Study group | Role | What they receive |
|---|---|---|
| Reinforced staple | Experimental | Endo GIA Reinforced Reload with Tri-Staple technology Receives: Device: Endo GIA Reinforced Reload with Tri-Staple technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula grade B/C
Measured: Ninety days after operation
Secondary outcomes (12)
Incidence of pancreatic fistula defined by ISGPF classification
Measured: Ninety days after operation
Incidence of pancreatic fistula grade C defined by ISGPF classification
Measured: Ninety days after operation
Incidence of intraabdominal bleeding
Measured: Ninety days after operation
Morbidity
Measured: Ninety days after operation
Mortality
Measured: Ninety days after operation
Postoperative hospital stay
Measured: Ninety days after operation
Hemostasis condition of staple line
Measured: during operation
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
Measured: during operation
Period of drain insertion
Measured: Ninety days after operation
Damage of pancreatic stump
Measured: during operation
Frequency of additional suture of pancreatic stump
Measured: during operation
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Measured: Ninety days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
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 Pancreatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- Hiroki Yamaue, M.D., Ph.D, Principal investigator, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270554
- Sponsor's protocol ID
- DP-Study 1401
- Status last verified
- Jul 2016
- First submitted
- 10 Oct 2014
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kawai M, Hirono S, Okada KI, Satoi S, Yanagimoto H, Kon M, Murakami Y, Kondo N, Sho M, Akahori T, Toyama H, Fukumoto T, Fujii T, Matsumoto I, Eguchi H, Ikoma H, Takeda Y, Fujimoto J, Yamaue H. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017 Dec;402(8):1197-1204. doi: 10.1007/s00423-017-1634-1. Epub 2017 Nov 4.
PubMed 29103084
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT02270554
- Acronym / sponsor ID
- DP-Study 1401
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Oct 2014 (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 aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
Detailed description
Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reinforced staple | Experimental | Device: Endo GIA Reinforced Reload with Tri-Staple technologyEndo GIA Reinforced Reload with Tri-Staple technology |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- disease of pancreatic body and tail
- PS (ECOG Performance Status Scale)0-1
- Age: 20 years or older
- distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
- Patients who can provide written informed consent
Key exclusion criteria (6 listed)
- Patients with severe ischemic cardiac disease
- Patients with severe liver cirrhosis or active hepatitis
- Patients with respiratory illness that requires oxygen administration
- Patients with chronic renal failure requiring dialysis
- Patients requiring other organ resection
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 |
|---|---|---|
| Endo GIA Reinforced Reload with Tri-Staple technologyDevice:Endo GIA Reinforced Reload with Tri-Staple technology | Device | Reinforced staple |
Primary outcome
Incidence of pancreatic fistula grade B/C
Time frame: Ninety days after operation
12 secondary outcomes
Incidence of pancreatic fistula defined by ISGPF classification
Time frame: Ninety days after operation
Incidence of pancreatic fistula grade C defined by ISGPF classification
Time frame: Ninety days after operation
Incidence of intraabdominal bleeding
Time frame: Ninety days after operation
Morbidity
Time frame: Ninety days after operation
Mortality
Time frame: Ninety days after operation
Postoperative hospital stay
Time frame: Ninety days after operation
Hemostasis condition of staple line
Time frame: during operation
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
Time frame: during operation
Period of drain insertion
Time frame: Ninety days after operation
Damage of pancreatic stump
Time frame: during operation
Frequency of additional suture of pancreatic stump
Time frame: during operation
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time frame: Ninety days 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 21 Jul 2016.
- Derived from this study: PubMed 29103084Kawai M, Hirono S, Okada KI, Satoi S, Yanagimoto H, Kon M, Murakami Y, Kondo N, Sho M, Akahori T, Toyama H, Fukumoto T, Fujii T, Matsumoto I, Eguchi H, Ikoma H, Takeda Y, Fujimoto J, Yamaue H. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017 Dec;402(8):1197-1204. doi: 10.1007/s00423-017-1634-1. Epub 2017 Nov 4.
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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.
Hiroki Yamaue, M.D., Ph.D principal investigator
Wakayama Medical University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endo GIA Reinforced Reload with Tri-Staple technology in people with Pancreatic Neoplasms, run by Wakayama Medical University at 11 sites 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 5 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 pancreatic fistula grade B/C (time frame: Ninety days 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 NCT02270554, 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 21 Jul 2016.