Improvement of Care of Patients Undergoing Pancreaticoduo... | NCT04668781

Studies
Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

NCT04668781

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Mar 14, 2025Actual

Enrollment

92Actual

Phase

Not Applicable

Conditions

Pancreatic Diseases
Pancreas Cancer

Interventions

Analgesia via epidural catheter
Analgesia via wound catheter

Countries

Finland

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

Mar 2025

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

Dec 21, 2020Actual

Primary Completion Date

Sep 18, 2024Actual

Completion Date

Dec 18, 2024Actual

First Submitted Date

Dec 9, 2020

First Submission Date that Met QC Criteria

Dec 9, 2020

First Posted Date

Dec 16, 2020Actual

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

Mar 11, 2025

Last Update Posted Date

Mar 14, 2025Actual

Name	Class
University of Helsinki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.

Detailed Description

All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural analgesia	Active Comparator		Procedure: Analgesia via epidural catheter
Wound catheter analgesia	Experimental		Procedure: Analgesia via wound catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analgesia via epidural catheter	Procedure	Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The norepinephrine consumption	Norepinephrine consumption on POD 0	Postoperative day 0

Secondary Outcomes

Measure	Description	Time Frame
Fluid volumes on PODs 0-4	Intraoperative and postoperative fluid volumes	Postoperative days 0-4
Oxycodone consumption	Intravenous PCA opioid consumption.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years or over
patients who undergo pancreaticoduodenectomy

Exclusion Criteria:

patients to whom are made a major vascular reconstruction
patients with significant comorbidities and inability to use PCA
regural use of strong opioids or drugs preoperatively
patients with severe chronic pain issues
chronic atrial fibrillation
patients who refuse to take part to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Helsinki	HUS	00029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010182	Pancreatic Diseases
D010190	Pancreatic Neoplasms
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided