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

NCT ID: NCT02456155

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

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.

Conditions

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Bedside Placement of Nasal Jejunal Tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasound group

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

Group Type EXPERIMENTAL

placing nasal jejunal tube with ultrasound

Intervention Type PROCEDURE

bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically

endoscope group

Conventional methods for placing Nasal Jejunal Tube

Group Type PLACEBO_COMPARATOR

placing nasal jejunal tube endoscopically

Intervention Type PROCEDURE

Interventions

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placing nasal jejunal tube with ultrasound

bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically

Intervention Type PROCEDURE

placing nasal jejunal tube endoscopically

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li Gang

OTHER

Sponsor Role lead

Responsible Party

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Li Gang

Jinling Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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JinLing hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gang Li, MD.

Role: CONTACT

+86-025-80861655

Facility Contacts

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ke lu, Ph.D

Role: primary

Other Identifiers

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110-92

Identifier Type: -

Identifier Source: org_study_id

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