A Trial of Bedside Placement of Nasal Jejunal Tube Confirmed by Ultrasound Compared to Placement by Endoscope in Patients With SAP

Study Overview
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Brief Summary
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The investigators assessed the utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis. Primary endpoint: Success rate. Secondary Endpoint: Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.

Detailed Description
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We set this randomised trial to assess the safety and utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis. Primary endpoint: Success rate. Secondary Endpoint: Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.

Official Title
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Study to Compare the Placement Method of Nasal Jejunal Tube in Patients With Severe Acute Pancreatitis: Bedside Placement With Ultrasound Confirmation Versus Placement Endoscopically

Conditions
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Bedside Placement of Nasal Jejunal Tube

Intervention / Treatment
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* Procedure: placing nasal jejunal tube with ultrasound
* Procedure: placing nasal jejunal tube endoscopically


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute pancreatitis patients who need enteral nutrition; patients in acute phase of pancreatitis (within 2 weeks from onset); the severity of pancreatitis is equal to or above moderate (according to the revised classification of pancreatitis). Exclusion Criteria: diagnosed with IAH(Intra-abdominal pressure) IV grade, abdominal compartment syndrome (ACS); patients who have circulatory failure; patients who have gastrointestinal bleeding; patients who have specific diseases such as chronic digestive diseases and autoimmune diseases; patients in pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound group<br>using B ultrasound as a instruction technique to place Nasal Jejunal Tube | Procedure: placing nasal jejunal tube with ultrasound<br>* bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically<br>|
| Placebo Comparator: endoscope group<br>Conventional methods for placing Nasal Jejunal Tube | Procedure: placing nasal jejunal tube endoscopically<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube | 24 hours | 
| Change of intra-abdominal pressure | the intra-abdominal pressure at 1h before, 1h after and 3 days after placement | 3 days | 
| Tolerance of enteral nutrition | nausea, vomiting, diarrhea, abdominal pain | 3 days | 
| Time interval to approach the target calories | The exact time interval from the placement of the tube to the time that the patient can tolerate the target enteral nutrition. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscope, bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, efficacy, safety