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Trial record 67 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy (PReHeBP)

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ClinicalTrials.gov Identifier: NCT02784353
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dae Wook Hwang, Asan Medical Center

Brief Summary:
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.

Condition or disease Intervention/treatment Phase
Hepatic Neoplasms Biliary Tract Neoplasms Pancreatic Neoplasms Behavioral: Perioperative rehabilitation program Behavioral: Conventional Not Applicable

Detailed Description:

The most important outcome in the management of HBP malignancies is survival. Since the application of ERAS (enhanced recovery after surgery), the improvement of QOL(quality of life) has been known as one of important factor for the management of HBP malignancies as well as survival, and the improvement of QOL, itself, affect the survival.

There are several reports that perioperative rehabilitation affect positively for the outcome of surgery and QOL in surgical patients. However, in the HBP field, there are rarely studied for this concept.

This study aim to investigate that the application of rehabilitation program for the surgery of HBP malignancies affect on short-term outcome and lead the improvement of QOL.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arm, parallel, randomized controlled study
Masking: Single (Outcomes Assessor)
Masking Description: The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
Primary Purpose: Supportive Care
Official Title: Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Conventional
No intervention; conventional perioperative management without perioperative rehabilitation program
Behavioral: Conventional
conventional perioperative management without rehabilitation program
Other Name: No intervention

Experimental: Intervention - PReHeBP
conventional perioperative management with preoperative and postoperative rehabilitation program
Behavioral: Perioperative rehabilitation program

Perioperative rehabilitation program

  • preoperative rehabilitation : 2 weeks prior to operation
  • postoperative rehabilitation : 3 months after operation
Other Name: PReHeBP




Primary Outcome Measures :
  1. The incidence and severity of general complication [ Time Frame: till postoperative 3 months ]
    Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification


Secondary Outcome Measures :
  1. The incidence of operation-specific complication [ Time Frame: till postoperative 3 months ]
    Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification

  2. The incidende of Mortality [ Time Frame: till postoperative 3 months ]
    Rate of in-hospital mortality and 90 days mortality

  3. Rate of re-admission [ Time Frame: till postoperative 3 months ]
    the rate of re-admission, till postoperative 3 months

  4. The changes in Quality of life [ Time Frame: Comparison between at the time of discharge and postoperative 3months ]
    changes in quality of life (EORTC QLQ-C30), at the time of discharge and 3 months after surgery

  5. Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation) [ Time Frame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery ]
    Compliance of Aerobic exercise, strength exercise and respiratory excursion based on exercise diary

  6. Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation) [ Time Frame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery ]
    Measure the 6 minutes walk test (m/minute)

  7. Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation) [ Time Frame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery ]
    Grasping power measurement using dynamometer



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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 <80 years old
  • ECOG 0-2
  • resectable HBP malignancies or premalignant lesions which should be required GI resection and anastomosis
  • open surgery
  • 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 disturbance in liver; 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 HBP tumor
  • active or uncontrolled infection
  • alcohol or other drug addiction
  • already enrolled patient in other study which affect this study
  • 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.)
  • previous history of neurological or musculoskeletal diseases which is impossible to allow investigator's order

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): NCT02784353


Contacts
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Contact: DAE WOOK HWANG, M.D. 82-2-3010-3939 dwhwang@amc.seoul.kr
Contact: WON KIM, M.D. 82-2-3010-1694 duocl79@gmail.com

Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 05505
Contact: DAE WOOK HWANG, M.D.    82-2-3010-3939    dwhwang@amc.seoul.kr   
Contact: WON KIM, M.D.    82-2-3010-1694    duocl79@gmail.com   
Principal Investigator: DAE WOOK HWANG, M.D.         
Principal Investigator: WON KIM, M.D.         
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: DAE WOOK HWANG, M.D. Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA

Publications of Results:

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Responsible Party: Dae Wook Hwang, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02784353     History of Changes
Other Study ID Numbers: PReHeBP
2015-665 ( Other Grant/Funding Number: Asan Medical Center )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dae Wook Hwang, Asan Medical Center:
Rehabilitation
Quality of life
Surgery
Hepatic neoplasms
Biliary tract neoplasms
Pancreatic neoplasms
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Biliary Tract Neoplasms
Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Biliary Tract Diseases
Liver Diseases