ERCPNCT04255095
Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis
A study testing experiment in people with ERCP, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- ERCP
- What is being tested?
- experiment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Jun 2021
- Phase
- Interventional
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.
- Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.
Who cannot join
- Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.
Trial locations and contacts
1 site in 1 country.
Z'hong'chao Zhu, Doctor contact
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Qiong Gong, Doctor, +86 18086496360, gongq201919@163.com
About this study
Official title: Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis
The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.
Read the detailed description
This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.
Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.
- Conditions
- ERCP
- Being tested
- experiment, control
- Keywords
- Pancreatic duct negative-pressure suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentProcedure or surgery
Also called Naso-pancreatic duct negative pressure attraction
Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。
controlProcedure or surgery
Also called naso-biliary drinage
Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。
| Study group | Role | What they receive |
|---|---|---|
| Nasobiliary drainage | Active comparator | Not described Receives: Procedure: control |
| Naso-pancreatic drainage(negative pressure) | Experimental | Not described Receives: Procedure: experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation
time from ERCP to ischarge
Measured: 2 months
complication rate
Pancreatitis aggravation， hemorrhage，fistula
Measured: 1 months
Secondary outcomes (2)
LOS(length of stay)
time from operation to discharge
Measured: postoperative period（1 month ）
death rate
Mortality from the disease
Measured: postoperative period（1 month ）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Oct 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255095
- Sponsor's protocol ID
- ERCP-0001
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis
- ClinicalTrials.gov ID
- NCT04255095
- Acronym / sponsor ID
- ERCP-0001
- Conditions
- ERCP
- Keywords
- Pancreatic duct negative-pressure suction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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 hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.
Detailed description
This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.
Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasobiliary drainage | Active comparator | Procedure: control |
| Naso-pancreatic drainage(negative pressure) | Experimental | Procedure: experiment |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.
- Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.
Key exclusion criteria (1 listed)
- Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.
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 |
|---|---|---|
| experimentAlso: Naso-pancreatic duct negative pressure attractionTreatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。 | Procedure or surgery | Naso-pancreatic drainage(negative pressure) |
| controlAlso: naso-biliary drinageTreatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。 | Procedure or surgery | Nasobiliary drainage |
Primary outcome
Rehabilitation
Time frame: 2 months
time from ERCP to ischarge
complication rate
Time frame: 1 months
Pancreatitis aggravation， hemorrhage，fistula
2 secondary outcomes
LOS(length of stay)
Time frame: postoperative period（1 month ）
death rate
Time frame: postoperative period（1 month ）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for ERCP
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Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
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Chronic Pancreatitis
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Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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.
Z'hong'chao Zhu, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experiment in people with ERCP, run by Renmin Hospital of Wuhan University 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 2 inclusion and 1 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 5 Feb 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Qiong Gong, Doctor (+8618086496360, gongq2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation (time frame: 2 months). The study lists 2 primary outcomes in all. 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 5 Feb 2020.