Bedside Placement of Nasal Jejunal TubePhase 1SAPNCT02456155
A Trial of Bedside Placement of Nasal Jejunal Tube Confirmed by Ultrasound Compared to Placement by Endoscope in Patients With SAP
A Phase 1 study testing placing nasal jejunal tube with ultrasound and placing nasal jejunal tube endoscopically in people with Bedside Placement of Nasal Jejunal Tube, run by Li Gang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bedside Placement of Nasal Jejunal Tube
- What is being tested?
- placing nasal jejunal tube with ultrasound and placing nasal jejunal tube endoscopically
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
JinLing hospital
Nanjing, Jiangsu, 210002
ke lu, Ph.D, kkb9832@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Bedside Placement of Nasal Jejunal Tube
- Being tested
- placing nasal jejunal tube with ultrasound, placing nasal jejunal tube endoscopically
- Keywords
- bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, endoscope, efficacy, safety
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placing nasal jejunal tube with ultrasoundProcedure or surgery
bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
placing nasal jejunal tube endoscopicallyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ultrasound group | Experimental | using B ultrasound as a instruction technique to place Nasal Jejunal Tube Receives: Procedure: placing nasal jejunal tube with ultrasound |
| endoscope group | Placebo comparator | Conventional methods for placing Nasal Jejunal Tube Receives: Procedure: placing nasal jejunal tube endoscopically |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
Measured: 24 hours
Secondary outcomes (4)
Adverse effects
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
Measured: 24 hours
Change of intra-abdominal pressure
the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
Measured: 3 days
Tolerance of enteral nutrition
nausea, vomiting, diarrhea, abdominal pain
Measured: 3 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bedside Placement of Nasal Jejunal TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Gang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Gang, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456155
- Sponsor's protocol ID
- 110-92
- Acronym
- SAP
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02456155
- Acronym / sponsor ID
- SAP / 110-92
- Conditions
- Bedside Placement of Nasal Jejunal Tube
- Keywords
- bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, endoscope, efficacy, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Li GangUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound group | Experimental | Procedure: placing nasal jejunal tube with ultrasoundusing B ultrasound as a instruction technique to place Nasal Jejunal Tube |
| endoscope group | Placebo comparator | Procedure: placing nasal jejunal tube endoscopicallyConventional methods for placing Nasal Jejunal Tube |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placing nasal jejunal tube with ultrasoundbedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically | Procedure or surgery | ultrasound group |
| placing nasal jejunal tube endoscopically | Procedure or surgery | endoscope group |
Primary outcome
Success rate
Time frame: 24 hours
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
4 secondary outcomes
Adverse effects
Time frame: 24 hours
Change of intra-abdominal pressure
Time frame: 3 days
Tolerance of enteral nutrition
Time frame: 3 days
Time interval to approach the target calories
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing placing nasal jejunal tube with ultrasound and placing nasal jejunal tube endoscopically in people with Bedside Placement of Nasal Jejunal Tube, run by Li Gang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Li, MD. (+86-025-80861655, nju8icu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.