DuodenopancreatectomySEALNCT00850291
Economisation of Whipple Resection Using Electrosurgical Sealing Device
An observational study of Duodenopancreatectomy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Duodenopancreatectomy
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Oct 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.
Who may be able to join
- resectable tumor
Who cannot join
- palliative resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Controlled, Randomized Study of Economisation of the Preparation in Partial Duodenopancreatectomy Using an Electrosurgical Sealing Device Versus Traditional Methods
Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.
- Conditions
- Duodenopancreatectomy
- Keywords
- Partial duodenopancreatectomy using electrosurgical vessel sealing device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Electrosurgical vessel sealing device | |
| 2 | traditional surgical methods:stitches and ligations |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DuodenopancreatectomyStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Jacob R. Izbicki, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850291
- Sponsor's protocol ID
- 2907
- Acronym
- SEAL
- Status last verified
- Jun 2017
- First submitted
- 23 Feb 2009
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. doi: 10.1053/j.seminoncol.2007.05.004.
PubMed 17674959Uzunoglu FG, Bockhorn M, Fink JA, Reeh M, Vettorazzi E, Gawad KA, Bogoevski D, Vashist YK, Tsui TY, Koenig A, Mann O, Izbicki JR. LigaSure vs. conventional dissection techniques in pancreatic surgery--a prospective randomised single-centre trial. J Gastrointest Surg. 2013 Mar;17(3):494-500. doi: 10.1007/s11605-012-2107-z. Epub 2012 Dec 19.
PubMed 23250820
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized Study of Economisation of the Preparation in Partial Duodenopancreatectomy Using an Electrosurgical Sealing Device Versus Traditional Methods
- ClinicalTrials.gov ID
- NCT00850291
- Acronym / sponsor ID
- SEAL / 2907
- Conditions
- Duodenopancreatectomy
- Keywords
- Partial duodenopancreatectomy using electrosurgical vessel sealing device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Feb 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.
Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Electrosurgical vessel sealing device |
| 2 | – | –traditional surgical methods:stitches and ligations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.
Key inclusion criteria (1 listed)
- resectable tumor
Key exclusion criteria (1 listed)
- palliative resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Jun 2017.
- Background: PubMed 17674959Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. doi: 10.1053/j.seminoncol.2007.05.004.
- Derived from this study: PubMed 23250820Uzunoglu FG, Bockhorn M, Fink JA, Reeh M, Vettorazzi E, Gawad KA, Bogoevski D, Vashist YK, Tsui TY, Koenig A, Mann O, Izbicki JR. LigaSure vs. conventional dissection techniques in pancreatic surgery--a prospective randomised single-centre trial. J Gastrointest Surg. 2013 Mar;17(3):494-500. doi: 10.1007/s11605-012-2107-z. Epub 2012 Dec 19.
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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.
Jacob R. Izbicki, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenopancreatectomy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 1 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 23 Jun 2017. 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 Germany. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850291, which also lists 2 linked publications.
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 Jun 2017.