ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

Summary

In the study, the enhanced recovery after surgery (ERAS) program is applied to total pancreatectomy (TP) and low-risk pancreaticoduodenectomy (PD) patients identified by a small number of acinar cells in the cut edge of the pancreas. The research setting is randomized and controlled. All patients arriving at the Tampere University Hospital (TAUH) for PD or TP surgery are recruited into the study. Recruited patients are randomized to the ERAS protocol and to the standard protocol recovery program. The ERAS program differs from the normal care protocol preoperatively, intraoperatively and postoperatively as explained in the following section.

In the ERAS protocol, both on the previous day of the surgery and on the following days, the patient is discussed with the patient about the benefits of the protocol used and the recovery program objectives. The purpose is to motivate and encourage the patient. On the day of surgery, the patient's intake of food and fluids is allowed to be closer to the surgery and the patient is also given a carbohydrate drink two hours before surgery. The nasogastric tube set at the beginning of surgery is removed at the end of the surgery and peripancreatic or perihepatic drains are not routinely placed. After surgery, drinking is allowed after four hours and the patient is encouraged to move as actively as possible in the bed. On the first and second postoperative day, the patient is allowed to enjoy normal food and drink according to his or her ability, and pancreatic capsules are given in the course of food. Additionally, the analgesic to be administered through the epidural cannula is dosed as far as possible to allow mobilization of the patient. The discussion on the benefits and recovery targets of the ERAS protocol are continued. On the third postoperative day, the epidural infusion is discontinued and the pain medication is moved to opioid-based pain management. This is continued until specific criteria for passing to the follow-up care are met.

Typical complications (pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage) are registered during hospitalization and their severity ratings according to ISGPS, ISPGF and Clavien-Dindo classifications are also determined. Other variables registered are the number of intensive care days, situations requiring new surgeries, 30 and 90 day mortality, the completion time of the criteria for passing to follow up care, and the total length of hospitalization. In addition, the need for readmissions is registered. The implementation of the ERAS protocol is followed by a separate tracking template, in which the nurses record the progress of the goals specified in the protocol on a daily basis. The results of the study are analyzed with the intention-to-treat principle.

Conditions

• Pancreatic Cancer
• Surgery--Complications
• Pancreatic Fistula
• Delayed Gastric Emptying
• Pancreatic Hemorrhage

Interventions

PROCEDURE

ERAS protocol preoperative actions

First appointment: \- Enlightenment on the benefits and objectives of the ERAS protocol Call to the patient day before the surgery: Discussing the course, benefits and goals of care in ERAS 4 dl PreOp drink before bedtime Operation day: Fluid intake allowed 2 hours before surgery 2 dl PreOP drink 2 h before cutting

PROCEDURE

ERAS protocol intraoperative actions

Intraoperative: Drains in the peripancreatic or perihepatic regions are not set unless the surgeon sees this particular reason The nasogastric tube is removed at the end of the surgery

PROCEDURE

ERAS protocol postoperative actions

Postoperatively: Mobilization with nurses assisted Drinks allowed after 4h surgery POP 1: Drinking and normal food Removal of urinary catheter Intravenous liquids only if needed Mobilization Pain management by epidural cannula Discussion of the ERAS protocol Pancreatin capsules per os before eating Postoperative day 2: \- Mobilization: As much as possible, autonomous movement Postoperative day 3: Ending epidural infusion cannula removal Mobilization as independently as possible Pain relief: oxycodone/naloxone p.o. to keep mobilization possible: Postoperative day 4: Support and encouragement continues Pain management at a level that allows mobility

Sponsors & Collaborators

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Johanna Laukkarinen, MD-PhD · Dept. of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Finland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-10-01

Completion

2021-10-01

Countries

• Finland

Study Locations