The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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Enhanced Recovery After Surgery (ERAS) is not a program that aims 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 are proven in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery.

Investigators performed Randomized Controlled Trials to evaluate the non-inferiority of modified ERAS protocol for pancreaticoduodenectomy (PD) by introducing standardized pre- and post-operative treatment based on ERAS treatment guidelines (ERAS on PD, Research Institute Clinical Progress, 2014-0961; ClinicalTrials.gov, NCT02372331). As a result of the study, the ERAS protocol proved to be non-inferior to the existing pre- and post-operative treatment in terms of surgical complications, mortality, hospital stay, total hospital cost, and most nutritional indicators.

However, the previous study did not include a few important intraoperative items such as epidural analgesia and fluid balance among the main items of the ERAS protocol. This trial aims to evaluate the clinical results by applying the complete ERAS protocol.

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Detailed Description

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This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD).

This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study.

Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate.

Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group.

Investigators plan to observe the clinical outcomes up to 3 months after surgery.

The primary outcome is the functional recovery date, and secondary outcomes are the postoperative complication rate, postoperative mortality, and readmission rate.

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 was not defined differently.

Conditions

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Periampullary Cancer Borderline Malignancy Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The evaluation and judgment for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.

Study Groups

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Conventional

Conventional ERAS program

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

complete ERAS program (Conventional ERAS program + Epidural analgesia + Fluid balance)

Group Type EXPERIMENTAL

ERAS perioperative management

Intervention Type OTHER

* Epidural analgesia
* Fluid balance
* Other items are the same as conventional

Interventions

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ERAS perioperative management

* Epidural analgesia
* Fluid balance
* Other items are the same as conventional

Intervention Type OTHER

Other Intervention Names

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Fast tract

Eligibility Criteria

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Inclusion Criteria

* Age: 18 to 80 years old
* Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
* Resectable or borderline resectable malignant tumor or borderline malignant tumor on the periampullary area
* No distant metastases
* Bone marrow function: White Blood Cell (WBC) at least 3,000/mm3 or Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelet count at least 125,000/mm3
* Liver function: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) less than 3 times the upper limit of normal
* Renal function: Creatinine no greater than 1.5 times the upper limit of normal
* Patients who consented and signed informed consent

Exclusion Criteria

* Patients with distant metastases or patients with recurrent periampullary carcinoma
* Patients with active or uncontrolled infection
* Patients with severe psychiatric/neurological disorders
* People who are addicted to alcohol or other drugs
* Patients included in other clinical studies that may affect this study
* Patients unable to follow the researcher's instructions
* Pregnancy
* Patients with uncontrolled heart disease
* Patients with moderate or more comorbidities that are judged to have an impact on quality of life or nutritional status (liver cirrhosis, chronic renal failure, heart failure, etc.)
* Patients who underwent major abdominal organ surgery other than scheduled pancreaticoduodenectomy.
* Patients who require combined resection of other major abdominal organs in addition to scheduled pancreaticoduodenectomy
* History of allergy to local anesthetics
* Local infection at the treatment site
* Patients with neurological or mental health conditions
* A history of spinal surgery or compression fractures at abdominal level
* Patients with coagulopathy (Platelet \< 125,000/mm3 or International Normalized Ratio (INR) ≥ 1.5) or who continue to take anticoagulants or antithrombotic drugs without stopping
* Others who are not suitable for research in the judgment of the clinician

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No