Resectable Pancreatic Head NeoplasmNCT01321450
Economisation of Whipple Resection Using an Ultrasonic Dissection Device
An observational study of Resectable Pancreatic Head Neoplasm and Resectable Periampullary Neoplasm, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in 3 countries.
Trial summary
Including 150 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 ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Head Neoplasm, Resectable Periampullary Neoplasm, Chronic Pancreatitis
- How many people
- 82 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2009to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
Including 150 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 ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.
- Conditions
- Resectable Pancreatic Head Neoplasm, Resectable Periampullary Neoplasm, Chronic Pancreatitis
- Medical subject headings
- Pancreatitis, Chronic
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 |
|---|---|---|
| Group A | Preparation with Harmonic WAVE | |
| Group B | Preparation with conventional modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operation time
Measurement of time regarding incision-closure-time
Measured: end of operation
Secondary outcomes (6)
intraoperative blood loss
Measured: end of operation
number of transfusions
Measured: within the first 24 hours perioperatively
hospitalization time
Measured: end of hospitalization
resulting cost reduction
Measured: end of hospitalization
pancreatic fistula
Measured: within the first 5 days postoperatively
postoperative intervention
Postoperative interventions due complications, e.g. pancreatic fistula
Measured: end of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Resectable Pancreatic Head NeoplasmStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob R. Izbicki, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321450
- Sponsor's protocol ID
- 2908
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2011
- Last updated
- 29 Jan 2019
- 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 17674959Hruby GW, Marruffo FC, Durak E, Collins SM, Pierorazio P, Humphrey PA, Mansukhani MM, Landman J. Evaluation of surgical energy devices for vessel sealing and peripheral energy spread in a porcine model. J Urol. 2007 Dec;178(6):2689-93. doi: 10.1016/j.juro.2007.07.121. Epub 2007 Oct 22.
PubMed 17945280Nicastri DG, Wu M, Yun J, Swanson SJ. Evaluation of efficacy of an ultrasonic scalpel for pulmonary vascular ligation in an animal model. J Thorac Cardiovasc Surg. 2007 Jul;134(1):160-4. doi: 10.1016/j.jtcvs.2007.02.015.
PubMed 17599502Uzunoglu FG, Stehr A, Fink JA, Vettorazzi E, Koenig A, Gawad KA, Vashist YK, Kutup A, Mann O, Gavazzi F, Zerbi A, Bassi C, Dervenis C, Montorsi M, Bockhorn M, Izbicki JR. Ultrasonic dissection versus conventional dissection techniques in pancreatic surgery: a randomized multicentre study. Ann Surg. 2012 Nov;256(5):675-9; discussion 679-80. doi: 10.1097/SLA.0b013e318271cefa.
PubMed 23095609
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT01321450
- Acronym / sponsor ID
- 2908
- Conditions
- Resectable Pancreatic Head Neoplasm, Resectable Periampullary Neoplasm, Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Mar 2011 (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 150 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 ultrasonic dissection 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 |
|---|---|---|
| Group A | – | –Preparation with Harmonic WAVE |
| Group B | – | –Preparation with conventional modalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Total operation time
Time frame: end of operation
Measurement of time regarding incision-closure-time
6 secondary outcomes
intraoperative blood loss
Time frame: end of operation
number of transfusions
Time frame: within the first 24 hours perioperatively
hospitalization time
Time frame: end of hospitalization
resulting cost reduction
Time frame: end of hospitalization
pancreatic fistula
Time frame: within the first 5 days postoperatively
postoperative intervention
Time frame: end of hospitalization
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 29 Jan 2019.
- 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.
- Background: PubMed 17945280Hruby GW, Marruffo FC, Durak E, Collins SM, Pierorazio P, Humphrey PA, Mansukhani MM, Landman J. Evaluation of surgical energy devices for vessel sealing and peripheral energy spread in a porcine model. J Urol. 2007 Dec;178(6):2689-93. doi: 10.1016/j.juro.2007.07.121. Epub 2007 Oct 22.
- Background: PubMed 17599502Nicastri DG, Wu M, Yun J, Swanson SJ. Evaluation of efficacy of an ultrasonic scalpel for pulmonary vascular ligation in an animal model. J Thorac Cardiovasc Surg. 2007 Jul;134(1):160-4. doi: 10.1016/j.jtcvs.2007.02.015.
- Derived from this study: PubMed 23095609Uzunoglu FG, Stehr A, Fink JA, Vettorazzi E, Koenig A, Gawad KA, Vashist YK, Kutup A, Mann O, Gavazzi F, Zerbi A, Bassi C, Dervenis C, Montorsi M, Bockhorn M, Izbicki JR. Ultrasonic dissection versus conventional dissection techniques in pancreatic surgery: a randomized multicentre study. Ann Surg. 2012 Nov;256(5):675-9; discussion 679-80. doi: 10.1097/SLA.0b013e318271cefa.
- UH Hamburg-Eppendorf - General, Visceral and Thoracic Surgery Department and ClinicLink provided by the sponsor.
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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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Pancreatic Head Neoplasm and Resectable Periampullary Neoplasm, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in 3 countries.
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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Greece, Italy. 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.
What does the primary outcome measure?
Total operation time (time frame: end of 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 NCT01321450, which also lists 4 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 29 Jan 2019.