Patients Who Undergo PancreatoduodenectomyPhase 3NCT01898780
Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy
A Phase 3 study testing pancreaticojejunostomy with horizontal mattress suture and pancreaticojejunostomy with interrupted suture in people with Patients Who Undergo Pancreatoduodenectomy, run by Wakayama Medical University at 1 site in Japan.
Trial summary
The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Who Undergo Pancreatoduodenectomy
- What is being tested?
- pancreaticojejunostomy with horizontal mattress suture and pancreaticojejunostomy with interrupted suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Jun 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from whom we obtained written informed consent of this study
Who cannot join
- Patients with severe ischemic cardiac disease
- Patients with severe liver damage
- Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
- Patients requiring dialysis treatment due to chronic renal failure
- Patients who are considered as inappropriate by attending physician
Trial locations and contacts
1 site in 1 country.
Japan1 site
Second Department of Surgery, Wakayama Medical University
Wakayama, 641-8510
About this study
The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.
- Being tested
- pancreaticojejunostomy with horizontal mattress suture, pancreaticojejunostomy with interrupted suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticojejunostomy with horizontal mattress sutureProcedure or surgery
pancreaticojejunostomy with interrupted sutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| horizontal mattress | Experimental | pancreaticojejunostomy with horizontal mattress suture Receives: Procedure: pancreaticojejunostomy with horizontal mattress suture |
| interrupted suture | Experimental | pancreaticojejunostomy with interrupted suture Receives: Procedure: pancreaticojejunostomy with interrupted suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of pancreatic fistula including ISGPF grade B and C
Measured: Ninety days after operation
Secondary outcomes (1)
The rates of postoperative complications
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 posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017
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 Patients Who Undergo PancreatoduodenectomyStudies 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898780
- Sponsor's protocol ID
- HOMING
- Status last verified
- Oct 2019
- First submitted
- 9 Jul 2013
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hirono S, Kawai M, Okada KI, Miyazawa M, Kitahata Y, Hayami S, Ueno M, Yamaue H. Modified Blumgart Mattress Suture Versus Conventional Interrupted Suture in Pancreaticojejunostomy During Pancreaticoduodenectomy: Randomized Controlled Trial. Ann Surg. 2019 Feb;269(2):243-251. doi: 10.1097/SLA.0000000000002802.
PubMed 29697455
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy
- ClinicalTrials.gov ID
- NCT01898780
- Acronym / sponsor ID
- HOMING
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2017 (actual)
- First posted
- 12 Jul 2013 (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 verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| horizontal mattress | Experimental | Procedure: pancreaticojejunostomy with horizontal mattress suturepancreaticojejunostomy with horizontal mattress suture |
| interrupted suture | Experimental | Procedure: pancreaticojejunostomy with interrupted suturepancreaticojejunostomy with interrupted suture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from whom we obtained written informed consent of this study
Key exclusion criteria (5 listed)
- Patients with severe ischemic cardiac disease
- Patients with severe liver damage
- Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
- Patients requiring dialysis treatment due to chronic renal failure
- Patients who are considered as inappropriate by attending physician
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 |
|---|---|---|
| pancreaticojejunostomy with horizontal mattress suture | Procedure or surgery | horizontal mattress |
| pancreaticojejunostomy with interrupted suture | Procedure or surgery | interrupted suture |
Primary outcome
The frequency of pancreatic fistula including ISGPF grade B and C
Time frame: Ninety days after operation
1 secondary outcome
The rates of postoperative complications
Time frame: Ninety days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Derived from this study: PubMed 29697455Hirono S, Kawai M, Okada KI, Miyazawa M, Kitahata Y, Hayami S, Ueno M, Yamaue H. Modified Blumgart Mattress Suture Versus Conventional Interrupted Suture in Pancreaticojejunostomy During Pancreaticoduodenectomy: Randomized Controlled Trial. Ann Surg. 2019 Feb;269(2):243-251. doi: 10.1097/SLA.0000000000002802.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 pancreaticojejunostomy with horizontal mattress suture and pancreaticojejunostomy with interrupted suture in people with Patients Who Undergo Pancreatoduodenectomy, 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 1 inclusion and 5 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 7 Oct 2019. 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?
Results are not available in the source record.
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 frequency of pancreatic fistula including ISGPF grade B and 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 NCT01898780, 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 7 Oct 2019.