Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JT 14375 | Other Identifier | JeffTrial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Protein Supplement | Experimental | 60 g total protein per day, administered via twice daily ensure max protein shakes |
|
| Control | No Intervention | No intervention on diet; routine dietary practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensure Max Protein | Dietary Supplement | Liquid shake with 30 g protein per serving |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications | All complications within 30 days of surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival time since surgery | 6 months |
| Prealbumin level | Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harish Lavu, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Not provided
Not provided
Not provided
Not provided
| 30 days |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |