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

Li Gang

Status and phase: Unknown; Phase 1

Conditions: Bedside Placement of Nasal Jejunal Tube

Treatments: Procedure: placing nasal jejunal tube endoscopically; Procedure: placing nasal jejunal tube with ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02456155

110-92

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

ultrasound group

Experimental group

Description:

using B ultrasound as a instruction technique to place Nasal Jejunal Tube

Treatment:

Procedure: placing nasal jejunal tube with ultrasound

endoscope group

Placebo Comparator group

Description:

Conventional methods for placing Nasal Jejunal Tube

Treatment:

Procedure: placing nasal jejunal tube endoscopically