Clinical trial · Interventional
Preoperative Nutritional Support in Malnutritional Cancer Patients
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
- 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)
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients. The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
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 Cancer | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nutritional support program | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nutritional support program apply
- description
- Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.
- interventionNames
- Dietary Supplement: nutritional support program
- type
- NO_INTERVENTION
- label
- historical control group
- description
- Historical control group is that did not receiving
Primary outcomes (1)
- measure
- postoperative complication
- timeFrame
- at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
- description
- expected the duration of hospital stay of postoperation is 4\~6 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer 2. Patients diagnosed with malnutrition (at least more than one) 1. PG-SGA B or C 2. Weight loss \>10% within 6 month 3. BMI \<18.5 4. Serum Albumin \<3.0 3. Age less than 80 years old over 20 years old 4. Performance status (ECOG scale): 0-1 5. Adequate organ functions 1. Hb ≥7.0 g/dl 2. ANC ≥1,500/mm3 3. PLT ≥80,000/mm3 4. Liver function: AST/ALT ≤5×upper limit of normal 5. Creatinine ≤2.0 ULN Exclusion Criteria: 1. Biopsy, drainage tube insertion, and other minor surgery 2. palliative surgery 3. Serious illness or medical conditions, as follows; 1. congestive heart failure (NYHA class III or IV) 2. unstable angina or myocardial infarction within the past 6 months, 3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block 4. uncontrolled hypertension 5. hepatic cirrhosis( ≥ Child class B) 6. interstitial pneumonia, pulmonary adenomatosis 7. psychiatric disorder that may interfere with and/or protocol compliance 8. unstable diabetes mellitus 9. uncontrolled ascites or pleural effusion 10. active infection 4. Pregnancy 5. Any patients judged by the investigator to be unfit to participate in the study
References
Publications (0)
Data not yet available