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

Phase 1

• Conditions: Bedside Placement of Nasal Jejunal Tube
• Interventions: Procedure: placing nasal jejunal tube with ultrasound; Procedure: placing nasal jejunal tube endoscopically

• Registration Number: NCT02456155
• Lead Sponsor: Li Gang

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-27
• Last Update Submitted: 2015-05-27
• Study First Posted: 2015-05-28
• Last Update Posted: 2015-05-28
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound group	placing nasal jejunal tube with ultrasound	using B ultrasound as a instruction technique to place Nasal Jejunal Tube
endoscope group	placing nasal jejunal tube endoscopically	Conventional methods for placing Nasal Jejunal Tube

Primary Outcome Measures

Name	Time	Method
Success rate	24 hours	Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

JinLing hospital; 🇨🇳 Nanjing, Jiangsu, China