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

May 27, 2015 updated by: Li Gang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Gang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110-92

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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