Economisation of Whipple Resection Using an Ultrasonic Di... | NCT01321450

Studies
Economisation of Whipple Resection Using an Ultrasonic Dissection Device

NCT01321450

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Jan 29, 2019Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Resectable Pancreatic Head Neoplasm
Resectable Periampullary Neoplasm
Chronic Pancreatitis

Interventions

Not provided

Countries

Germany
Greece
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009Actual

Primary Completion Date

Jul 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Mar 21, 2011

First Posted Date

Mar 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Preparation with Harmonic WAVE
Group B		Preparation with conventional modalities

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total operation time	Measurement of time regarding incision-closure-time	end of operation

Secondary Outcomes

Measure	Description	Time Frame
intraoperative blood loss		end of operation
number of transfusions		within the first 24 hours perioperatively
hospitalization time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob R. Izbicki, Prof. Dr.	Universitätsklinikum Hamburg-Eppendorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH Eppendorf		Hamburg		22529	Germany
Agia Olga hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17674959	Background	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.
17945280	Background	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. doi: 10.1016/j.juro.2007.07.121. Epub 2007 Oct 22.

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease