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Hepatic NeoplasmsPReHeBPNCT02784353

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

A study testing Perioperative rehabilitation program and Conventional in people with Hepatic Neoplasms and Biliary Tract Neoplasms, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Perioperative rehabilitation program and Conventional
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteSouth Korea
Study dates
4 Oct 2016to 24 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy

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

Read the 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.

Being tested
Perioperative rehabilitation program, Conventional
Keywords
Rehabilitation, Quality of life, Surgery, Hepatic neoplasms, Biliary tract neoplasms, Pancreatic neoplasms
Medical subject headings
Liver Neoplasms, Biliary Tract Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perioperative rehabilitation programBehavioural

    Also called PReHeBP

    Perioperative rehabilitation program

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

  • ConventionalBehavioural

    Also called No intervention

    conventional perioperative management without rehabilitation program

Study groups in NCT02784353
Study groupRoleWhat they receive
ConventionalActive comparatorNo intervention; conventional perioperative management without perioperative rehabilitation program
Receives: Behavioral: Conventional
Intervention - PReHeBPExperimentalconventional perioperative management with preoperative and postoperative rehabilitation program
Receives: Behavioral: Perioperative rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and severity of general complication

    Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification

    Measured: till postoperative 3 months

Secondary outcomes (7)

  1. The incidence of operation-specific complication

    Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification

    Measured: till postoperative 3 months

  2. The incidende of Mortality

    Rate of in-hospital mortality and 90 days mortality

    Measured: till postoperative 3 months

  3. Rate of re-admission

    the rate of re-admission, till postoperative 3 months

    Measured: till postoperative 3 months

  4. The changes in Quality of life

    changes in quality of life (EORTC QLQ-C30), at the time of discharge and 3 months after surgery

    Measured: Comparison between at the time of discharge and postoperative 3months

  5. Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation)

    Compliance of Aerobic exercise, strength exercise and respiratory excursion based on exercise diary

    Measured: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery

  6. Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)

    Measure the 6 minutes walk test (m/minute)

    Measured: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery

  7. Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)

    Grasping power measurement using dynamometer

    Measured: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study start4 Oct 2016
  3. Primary completion24 May 2021
  4. Study completion24 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 arm, parallel, randomized controlled study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784353
Sponsor's protocol ID
PReHeBP
Other IDs
2015-665
Acronym
PReHeBP
Status last verified
Nov 2022
First submitted
6 May 2016
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

    PubMed 5523831

  • Ford-Smith CD, Wyman JF, Elswick RK Jr, Fernandez T. Reliability of stationary dynamometer muscle strength testing in community-dwelling older adults. Arch Phys Med Rehabil. 2001 Aug;82(8):1128-32. doi: 10.1053/apmr.2001.24291.

    PubMed 11494194

  • Johansson K, Tibe K, Weibull A, Newton RC. Low intensity resistance exercise for breast cancer patients with arm lymphedema with or without compression sleeve. Lymphology. 2005 Dec;38(4):167-80.

    PubMed 16515225

  • Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.1007/s00268-015-2988-6.

    PubMed 25651963

  • Schwartz AL. Fatigue mediates the effects of exercise on quality of life. Qual Life Res. 1999 Sep;8(6):529-38. doi: 10.1023/a:1008978611274.

    PubMed 10548868

  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

    PubMed 21205966

  • Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7.

    PubMed 22321518

  • Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. doi: 10.1023/B:QURE.0000021692.81214.70.

    PubMed 15129896

  • Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

    PubMed 10960937

  • Bobbio A, Chetta A, Ampollini L, Primomo GL, Internullo E, Carbognani P, Rusca M, Olivieri D. Preoperative pulmonary rehabilitation in patients undergoing lung resection for non-small cell lung cancer. Eur J Cardiothorac Surg. 2008 Jan;33(1):95-8. doi: 10.1016/j.ejcts.2007.10.003. Epub 2007 Nov 19.

    PubMed 18006327

  • Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):65-71; discussion 71-2. doi: 10.1002/sim.4780090113.

    PubMed 2345839

Questions about this trial

What is this clinical trial studying?

A study testing Perioperative rehabilitation program and Conventional in people with Hepatic Neoplasms and Biliary Tract Neoplasms, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of general complication (time frame: till postoperative 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784353, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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