NCT03757455

ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

Terminated NA Last updated 9 December 2021

What this trial tests

NA trial testing ERAS protocol preoperative actions in Pancreatic Cancer in 35 participants. Terminated before completion.

Timeline

1 September 2020

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	Tampere University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	35
Start date	1 September 2020
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	1 location across Finland

Drugs / interventions tested

• ERAS protocol preoperative actions
• ERAS protocol intraoperative actions
• ERAS protocol postoperative actions

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Surgery--Complications — all drugs for Surgery--Complications →
• Pancreatic Fistula — all drugs for Pancreatic Fistula →
• Delayed Gastric Emptying — all drugs for Delayed Gastric Emptying →

Sponsor

Tampere University Hospital

Who can join

Adults 18 to 99, any sex, with Pancreatic Cancer or Surgery--Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.