potentially resectable hepatobiliary and pancreatic cases
Conditions
Interventions
Squatting, standing on one leg, and walking 4,000 to 5,000 steps per day (40 minutes) in the 2 weeks prior to admission
Sponsors
Tohoku Medical and Pharmaceutical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients clinically ill with hepatobiliary-pancreatic disease for whom surgery is contemplated. (2) Patients over 65 years old. (3) In addition to 2 above, all patients with possible sarcopenia will be considered regardless of age. The diagnosis of possible sarcopenia will be evaluated according to the AWGS 2019 sarcopenia diagnostic criteria as described below. (4) Eligible surgical procedures will be as follows (all procedures will include both laparoscopic and open procedures) (a)Liver resection cases (b) Pancreatectomy (5) Cases with PS (ECOG classification) of 0 to 1 (6) Cases in which functions of major organs (bone marrow, liver, kidney, lung, etc.) are preserved (The following criteria are met according to laboratory values within 14 days prior to enrollment.) White blood cell count: greater than 3,500/mm3 and less than 12,000/mm3 Neutrophil count: 2,000/mm3 or more Hemoglobin level: 9.0 g/dl or greater Platelet count: 100,000/mm3 or greater Total bilirubin: 2.0 mg/dL or less*. Patients undergoing yellowing reduction for obstructive jaundice are expected to have a level of 3.0 mg/dL or less at the time of surgery. AST and ALT levels: 150 U/L or less Creatinine: 1.2 mg/dl or less (7) Cases in which oral intake is possible (8) Patients who have given written consent to be a subject in this study (9)Patients who are at least 20 years of age at the time of consent and have sufficient judgment to obtain consent for this study. (10)Cases in which the subject has been fully informed of the details of the study and has given his/her written consent.
Exclusion criteria
Exclusion criteria: (1) Patients with pulmonary fibrosis or interstitial pneumonia (2) Patients with malignant tumors that are expected to have no gross residual cancer at the time of resection. (3) Patients with active multiple cancers. Simultaneous overlapping cancers or disease-free period of less than 3 years. However, intraepithelial and intramucosal cancers are not included. (4) Active infection (e.g., fever > 38.0 degrees Celsius) (5) Patients using flucytosine, phenytoin, or warfarin (6) Pregnant or possibly pregnant (7) Other conditions deemed by the attending physician to be inappropriate for the safe conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prehabilitation Achievement and Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Perioperative complications (evaluated by Clavien-Dindon classification) (2) Length of hospital stay and postoperative hospital stay (3) Disease free survival (DFS) (4) Over all survival (OS) (5) Change in quality of life (EORTC-QLQ-C30, FACT-HEP) (6) Change in depression assessment (HADS) (7) Nutritional assessment (In Body, blood test, CT iliopsoas assessment) | — |
Countries
Japan
Contacts
Public ContactHiroto Sakurai
Tohoku Medical and Pharmaceutical University Hospital Hepatobiliary and pancreatic surgery
Outcome results
None listed