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Completed

NCT Number: NCT02372331

The Effect of ERAS 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.

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Key information

Conditions

Periampullary Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138736, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS perioperative management

Other
  • 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

Primary outcomes

  1. Morbidity

    Time frame: 3 months

    The incidence of operation-related morbidity

Secondary outcomes

  1. Mortality

    Time frame: 3 months

    The incidence of 30 days mortality and in-hospital mortality

  2. length of stay

    Time frame: 3 months

    postoperative length of stay

  3. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: ERAS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2015
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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