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The Effect of ERAS on Pancreaticoduodenectomy (ERAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372331
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dae Wook Hwang, Asan Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Periampullary Tumor Other: ERAS perioperative management Not Applicable

Detailed Description:
  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The evaluation and judgement 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.
Primary Purpose: Treatment
Official Title: The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
Actual Study Start Date : March 4, 2015
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 26, 2017

Arm Intervention/treatment
No Intervention: Conventional perioperative management
  • Preop usual biliary drainage
  • Preop smoking and alcohol
  • Preop parenteral nutrition
  • Oral bowel preparation (mechanical bowel preparation )
  • Preoperative fasting > 12 hours
  • Pre-anesthetic medication
  • Anti-thrombotic prophylaxis
  • Antimicrobial prophylaxis and skin preparation
  • Intravenous analgesia : PCA
  • Prevention of postoperative nausea and vomiting (PONV) (X)
  • Incision : surgeon direction
  • Avoiding hypothermia
  • Nasogastric intubation (O)
  • Postop glycemic control
  • Positive fluid balance
  • Perianastomotic drain removal over POD #5
  • Somatostatin analogues
  • Transurethral catheter removal
  • Delayed gastric emptying(DGE) (+) , parenteral nutrition (+)
  • Postop routine artificial nutrition (O), soft diet at POD #5
  • Early and scheduled mobilization
Experimental: ERAS perioperative management
  • behavioral intervention (counselling, audit)
  • dietary supplement
  • procedure (preoperative and postoperative)
  • drug
Other: ERAS perioperative management
  • 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 Name: Fast tract




Primary Outcome Measures :
  1. Morbidity [ Time Frame: 3 months ]
    The incidence of operation-related morbidity


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372331


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Dae Wook Hwang, M.D. Asan Medical Center
Publications:

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Responsible Party: Dae Wook Hwang, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02372331    
Other Study ID Numbers: ERAS
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At initial status of this study, IRB was approved at limited data access only.
Keywords provided by Dae Wook Hwang, Asan Medical Center:
pancreaticoduodenectomy
ERAS
Whipple's operation
Fast track