Economisation of Whipple Resection Using an Ultrasonic Dissection Device

Chronic Pancreatitis Clinical Trial

Official title:

Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321450
• Other study ID #: 2908
• Status: Completed
• Start date: March 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 performed for patients undergoing partial pancreatoduodenectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Head and Neck Neoplasms
• Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Resectable Pancreatic Head Neoplasm
• Resectable Periampullary Neoplasm

Locations

Country	Name	City	State
Germany	UH Eppendorf	Hamburg
Greece	Agia Olga hospital	Athens
Italy	UH Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Germany,  Greece,  Italy, 

References & Publications (3)

Hruby 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. Epub 2007 Oct 22. — View Citation

Nicastri 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. — View Citation

Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total operation time	Measurement of time regarding incision-closure-time	end of operation
Secondary	intraoperative blood loss		end of operation
Secondary	number of transfusions		within the first 24 hours perioperatively
Secondary	hospitalization time		end of hospitalization
Secondary	resulting cost reduction		end of hospitalization
Secondary	pancreatic fistula		within the first 5 days postoperatively
Secondary	postoperative intervention	Postoperative interventions due complications, e.g. pancreatic fistula	end of hospitalization

External Links

•   UH Hamburg-Eppendorf - General, Visceral and Thoracic Surgery Department and Clinic