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The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP).
The hypothesis:
Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria:
Inclusion criteria:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral nutrition | Experimental | In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours. |
|
| Nil-by-mouth treatment | No Intervention | The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition | Dietary Supplement | Same as arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| SIRS (Systemic Inflammatory Response Syndrome) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 4 weeks | |
| Organ failure (cardiovascular, respiratory, renal) | 4 weeks | |
| Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davor Štimac, MD, PhD | Department of Gastroenterology, University Hospital Rijeka | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27107634 | Derived | Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D019283 | Pancreatitis, Acute Necrotizing |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| 4 weeks |
| Local septic complications | 4 weeks |
| Other infections | 4 weeks |
| Inflammatory response (CRP on the first and third day) | First and third day of admission |
| Length of hospital stay | 4 weeks |
| Adverse events | 4 weeks |