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Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Primary Purpose

Pancreatic Diseases, Pancreas Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Analgesia via epidural catheter

Analgesia via wound catheter

About this trial

This is an interventional treatment trial for Pancreatic Diseases focused on measuring pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18 years or over
patients who undergo pancreaticoduodenectomy without vascular recostruction

Exclusion Criteria:

patients to whom are made a vascular reconstruction
patients who have significantly elevated risk for complications
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

Sites / Locations

Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Epidural analgesia

Wound catheter analgesia

Arm Description

Outcomes

Primary Outcome Measures

Fluid volume intraoperatively and postoperatively

The amount of fluid (crystalloids and albumin) patients have got during the surgery and postoperatively (ml/kg).

Secondary Outcome Measures

The amount of used norepinephrine

The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg).

Total dose of oxycodone

The amount of oxycodone patients have dosed via i.v. PCA pump (mg).

Hospital length of stay

Postoperative complications

Clavien-Dindo complications (scale 0-5), pancreatic fistulas (ISGPF definition, grade A-C), postpancreatectomy hemorrage (IPGPS definition, grade A-C), delayed gastric emptying (ISGPS definition, grade A-C).

Reoperation rates

Readmission rates

Mortality

Full Information

NCT ID

NCT04668781

First Posted

December 9, 2020

Last Updated

September 21, 2023

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT04668781

Brief Title

Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Official Title

Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 21, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 get additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Diseases, Pancreas Cancer

Keywords

pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Epidural analgesia

Arm Type

Active Comparator

Arm Title

Wound catheter analgesia

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Analgesia via epidural catheter

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Analgesia via wound catheter

Intervention Description

Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Primary Outcome Measure Information:

Title

Fluid volume intraoperatively and postoperatively

Description

The amount of fluid (crystalloids and albumin) patients have got during the surgery and postoperatively (ml/kg).

Time Frame

postoperative day 0-7

Secondary Outcome Measure Information:

Title

The amount of used norepinephrine

Description

The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg).

Time Frame

postoperative day 0-7

Title

Total dose of oxycodone

Description

The amount of oxycodone patients have dosed via i.v. PCA pump (mg).

Time Frame

postoperative day 0-7

Title

Hospital length of stay

Time Frame

postoperative day 0-60

Title

Postoperative complications

Description

Time Frame

postoperative day 0-30

Title

Reoperation rates

Time Frame

postoperative day 0-30

Title

Readmission rates

Time Frame

postoperative day 0-30

Title

Mortality

Time Frame

postoperative day 0-90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18 years or over patients who undergo pancreaticoduodenectomy without vascular recostruction Exclusion Criteria: patients to whom are made a vascular reconstruction patients who have significantly elevated risk for complications 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Piia Peltoniemi, M.D.

Phone

+35894711

piia.peltoniemi@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Pertti Pere, Ass.Prof

Phone

+35894711

pertti.pere@hus.fi

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

HUS

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Contact: