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The Effect of ERAS on Pancreaticoduodenectomy (ERAS)

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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

Tracking Information
First Submitted Date  ICMJE February 12, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE March 4, 2015
Actual Primary Completion Date May 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Morbidity [ Time Frame: 3 months ]
The incidence of operation-related morbidity
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Morbidity [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • Mortality [ Time Frame: 3 months ]
    The incidence of 30 days mortality and in-hospital mortality
  • length of stay [ Time Frame: 3 months ]
    postoperative length of stay
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Mortality [ Time Frame: 3 months ]
  • length of stay [ Time Frame: 3 months ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of ERAS on Pancreaticoduodenectomy
Official Title  ICMJE The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Periampullary Tumor
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: ERAS perioperative management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
276
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 26, 2017
Actual Primary Completion Date May 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372331
Other Study ID Numbers  ICMJE ERAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: At initial status of this study, IRB was approved at limited data access only.
Responsible Party Dae Wook Hwang, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dae Wook Hwang, M.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP