Clinical trial · Interventional
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy
NCT02784353CI-TRIAL-00062240PReHeBPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Hepatic Neoplasms | Liver Neoplasm | ALIAS | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional | Behavioral | — | UNRESOLVED |
| Perioperative rehabilitation program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional
- description
- No intervention; conventional perioperative management without perioperative rehabilitation program
- interventionNames
- Behavioral: Conventional
- type
- EXPERIMENTAL
- label
- Intervention - PReHeBP
- description
- conventional perioperative management with preoperative and postoperative rehabilitation program
- interventionNames
- Behavioral: Perioperative rehabilitation program
Primary outcomes (1)
- measure
- The incidence and severity of general complication
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (11)
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- RESULTFord-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. PMID 11494194
- RESULTJohansson 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. PMID 16515225
- RESULTOtsuji 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. PMID 25651963
- RESULTSchwartz 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. PMID 10548868
- RESULTStudenski 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. PMID 21205966
- RESULTYeo 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.