The Effect of ERAS on Pancreaticoduodenectomy (ERAS)

June 8, 2017 updated by: Dae Wook Hwang, Asan Medical Center

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.
  • The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.
  • Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.
  • Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years old or <75 years old
  • ECOG 0-2
  • resectable periampullary cancer or borderline malignancy
  • no distant metastasis
  • no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
  • no functional disturtance in liver; Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
  • no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal
  • informed consent

Exclusion Criteria:

  • distant metastasis (+) or recurred periampullary tumor
  • active or uncontrolled infection
  • uncontrolled psychiatric or neurologic problems
  • alcohol or other drug addiction
  • already enrolled patient in other study which affect this study
  • the patient who is impossible to allow investigator's order
  • pregnant or the possibility of pregnancy (+)
  • uncontrolled cardiopulmonary disease
  • moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)
  • previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)
  • in preoperative period, expected combined resection of other gastrointestinal organ including portal vein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional perioperative management
  • Preop usual biliary drainage
  • Preop smoking and alcohol
  • Preop parenteral nutrition
  • Oral bowel preparation (mechanical bowel preparation )
  • Preoperative fasting > 12 hours
  • Pre-anesthetic medication
  • Anti-thrombotic prophylaxis
  • Antimicrobial prophylaxis and skin preparation
  • Intravenous analgesia : PCA
  • Prevention of postoperative nausea and vomiting (PONV) (X)
  • Incision : surgeon direction
  • Avoiding hypothermia
  • Nasogastric intubation (O)
  • Postop glycemic control
  • Positive fluid balance
  • Perianastomotic drain removal over POD #5
  • Somatostatin analogues
  • Transurethral catheter removal
  • Delayed gastric emptying(DGE) (+) , parenteral nutrition (+)
  • Postop routine artificial nutrition (O), soft diet at POD #5
  • Early and scheduled mobilization
Experimental: ERAS perioperative management
  • behavioral intervention (counselling, audit)
  • dietary supplement
  • procedure (preoperative and postoperative)
  • drug
Other: ERAS perioperative management
  • Preop Counseling
  • Preop biliary drainage (X) when Serum Total bilirubin < 14.62mg/dl and cholangitis (-)
  • Preop enteral nutrition
  • Oral bowel preparation (mechanical bowel preparation ) (X)
  • Preop fasting < 6 hours
  • Prevention of postoperative nausea and vomiting (PONV) (O)
  • Nasogastric intubation (X)
  • Near-zero fluid balance
  • Somatostatin analogues (X)
  • Postop routine artificial nutrition (X), soft diet at POD #2
  • Audit
  • Other items are same as conventional
Other Names:
  • Fast tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 3 months
The incidence of operation-related morbidity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 3 months
The incidence of 30 days mortality and in-hospital mortality
3 months
length of stay
Time Frame: 3 months
postoperative length of stay
3 months
nutritional status
Time Frame: 3 months
The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2~3months.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Dae Wook Hwang, M.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2015

Primary Completion (Actual)

May 10, 2017

Study Completion (Actual)

May 26, 2017

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At initial status of this study, IRB was approved at limited data access only.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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