Post-ERCP Acute PancreatitisNCT02830984
ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
A study testing EST+LBD+ENBD and EST+LBD in people with Post-ERCP Acute Pancreatitis, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- EST+LBD+ENBD and EST+LBD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter. - Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Who cannot join
- Bleeding diathesis
- Prior EST or EPBD or ENBD
- Billroth II or Roux-en-Y anatomy
- Distal extrahepatic bile duct stenosis
- Acute pancreatitis
- Intrahepatic bile duct stones.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Hefei, Anhui, 230001
Shao Feng, MD, 8613033090788, tagsmile1985@163.com
About this study
Official title: Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones
Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In those studies, the authors suggested that EST plus LBD might lower the risk of post procedure pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative pancreatitis in treating of large bile duct stones.The investigators therefore designed a prospective randomized trial to determine whether nasobiliary drainage prevent PEP after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
Read the detailed description
Patients enrolled were confirmed the presence of CBD stones using magnetic resonance cholangiopancreatography. Patients with large bile duct stones were randomly assigned to EST+LBD+ENBD group and EST+LBD group. A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- EST+LBD+ENBD, EST+LBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EST+LBD+ENBDProcedure or surgery
Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
EST+LBDProcedure or surgery
Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
| Study group | Role | What they receive |
|---|---|---|
| EST+LBD+ENBD group | Experimental | Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones Receives: Procedure: EST+LBD+ENBD |
| EST+LBD group | Active comparator | Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones Receives: Procedure: EST+LBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).
Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Measured: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups
Secondary outcomes (1)
Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.
Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.
Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Measured: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute PancreatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shao Feng, MD, Principal investigator, Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830984
- Sponsor's protocol ID
- ENBD-001
- Status last verified
- Jul 2016
- First submitted
- 9 Jul 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones
- ClinicalTrials.gov ID
- NCT02830984
- Acronym / sponsor ID
- ENBD-001
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Jul 2016 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In those studies, the authors suggested that EST plus LBD might lower the risk of post procedure pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative pancreatitis in treating of large bile duct stones.The investigators therefore designed a prospective randomized trial to determine whether nasobiliary drainage prevent PEP after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
Detailed description
Patients enrolled were confirmed the presence of CBD stones using magnetic resonance cholangiopancreatography. Patients with large bile duct stones were randomly assigned to EST+LBD+ENBD group and EST+LBD group. A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EST+LBD+ENBD group | Experimental | Procedure: EST+LBD+ENBDNasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones |
| EST+LBD group | Active comparator | Procedure: EST+LBDWithout nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter. - Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Key exclusion criteria (6 listed)
- Bleeding diathesis
- Prior EST or EPBD or ENBD
- Billroth II or Roux-en-Y anatomy
- Distal extrahepatic bile duct stenosis
- Acute pancreatitis
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 |
|---|---|---|
| EST+LBD+ENBDNasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones | Procedure or surgery | EST+LBD+ENBD group |
| EST+LBDWithout nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones | Procedure or surgery | EST+LBD group |
Primary outcome
The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
Time frame: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
1 secondary outcome
Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.
Time frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Shao Feng, MD principal investigator
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EST+LBD+ENBD and EST+LBD in people with Post-ERCP Acute Pancreatitis, run by Anhui Provincial Hospital 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 6 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 7 Mar 2017. 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 Shao Feng, MD (8613033090788, tagsmile1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones. (time frame: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups). 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 7 Mar 2017.