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

Primary Purpose

Bedside Placement of Nasal Jejunal Tube

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
placing nasal jejunal tube with ultrasound
placing nasal jejunal tube endoscopically
Sponsored by
Li Gang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bedside Placement of Nasal Jejunal Tube focused on measuring bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, endoscope, efficacy, safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • JinLing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ultrasound group

endoscope group

Arm Description

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

Conventional methods for placing Nasal Jejunal Tube

Outcomes

Primary Outcome Measures

Success rate
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.

Secondary Outcome Measures

Adverse effects
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
Change of intra-abdominal pressure
the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
Tolerance of enteral nutrition
nausea, vomiting, diarrhea, abdominal pain
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.

Full Information

First Posted
May 5, 2015
Last Updated
May 27, 2015
Sponsor
Li Gang
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1. Study Identification

Unique Protocol Identification Number
NCT02456155
Brief Title
A Trial of Bedside Placement of Nasal Jejunal Tube Confirmed by Ultrasound Compared to Placement by Endoscope in Patients With SAP
Acronym
SAP
Official Title
Study to Compare the Placement Method of Nasal Jejunal Tube in Patients With Severe Acute Pancreatitis: Bedside Placement With Ultrasound Confirmation Versus Placement Endoscopically
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Gang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bedside Placement of Nasal Jejunal Tube
Keywords
bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, endoscope, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound group
Arm Type
Experimental
Arm Description
using B ultrasound as a instruction technique to place Nasal Jejunal Tube
Arm Title
endoscope group
Arm Type
Placebo Comparator
Arm Description
Conventional methods for placing Nasal Jejunal Tube
Intervention Type
Procedure
Intervention Name(s)
placing nasal jejunal tube with ultrasound
Intervention Description
bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
Intervention Type
Procedure
Intervention Name(s)
placing nasal jejunal tube endoscopically
Primary Outcome Measure Information:
Title
Success rate
Description
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Adverse effects
Description
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
Time Frame
24 hours
Title
Change of intra-abdominal pressure
Description
the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
Time Frame
3 days
Title
Tolerance of enteral nutrition
Description
nausea, vomiting, diarrhea, abdominal pain
Time Frame
3 days
Title
Time interval to approach the target calories
Description
The exact time interval from the placement of the tube to the time that the patient can tolerate the target enteral nutrition.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Li, MD.
Phone
+86-025-80861655
Email
nju8icu@126.com
Facility Information:
Facility Name
JinLing hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ke lu, Ph.D
Email
kkb9832@gmail.com

12. IPD Sharing Statement

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

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