ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

NCT03757455 | Terminated

• 1 other identifier: R18125
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Days until discharge from university hospital

  Time in days since the entry to hospital on the surgery day to the discharge day to follow up care or home

  Up to 24 weeks

Secondary Outcomes (3)

• Days until discharge from follow up care

  Up to 24 weeks

• Total number of complications

  Postoperatively up to 24 weeks

• Readmission frequency

  From the discharge up to 24 weeks for any cause related to surgery

Study Arms (2)

Enchanced recovery after surgery protocol

EXPERIMENTAL

ERAS-protocol as described in low risk patients after pancreaticoduodenectomy or total pancreatectomy

Procedure: ERAS protocol preoperative actions; Procedure: ERAS protocol intraoperative actions; Procedure: ERAS protocol postoperative actions

Standard protocol

NO INTERVENTION

Standard recovery protocol after pancreaticoduodenectomy or total pancreatectomy

Interventions

ERAS protocol preoperative actions PROCEDURE

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

Enchanced recovery after surgery protocol

ERAS protocol intraoperative actions PROCEDURE

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

Enchanced recovery after surgery protocol

ERAS protocol postoperative actions PROCEDURE

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

Enchanced recovery after surgery protocol

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All PD or TP patients 18-99 years old

You may not qualify if:

• Any other surgery than PD or TP
• High risk patients
• Refusal for the study

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital Deparment of Gastroenterologic Surgery

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Johanna Laukkarinen, MD-PhD

  Dept. of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 29, 2018
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FI (1)