Acute Biliary PancreatitisNCT02668081
Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis
A study testing Endoscopic papillary balloon dilation and Endoscopic sphincterotomy in people with Acute Biliary Pancreatitis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups.Moreover, the… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Acute Biliary Pancreatitis
- What is being tested?
- Endoscopic papillary balloon dilation and Endoscopic sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acute gallstone pancreatitis and fulfill any two items from a to c, plus one item in d, and e:
- abdominal pain typical of pancreatitis;
- elevation of serum amylase and/or lipase up to three times above normal;
- imaging studies (abdominal ultrasound or abdominal computed tomography) showed evidence of pancreatitis
- common bile duct stones, acute cholangitis (Charcot's triad), total bilirubin (total bilirubin)> 4mg / dL, bile duct dilatation (diameter> 6mm with intact gallbladder, or> 10mm when the gallbladder has been removed) plus total bilirubin 1.8 ~ 4mg / dL;
- exclude other causes of acute pancreatitis.
Who cannot join
- septic shock
- serious coagulopathy (international normalized ratio 1.5, partial thromboplastin time greater than twice that of control, platelet count <50 x 1000 / Cumm)
- malignant tumors of the biliary and pancreatic tract
- severe cardiovascular or mental illness which can not cooperate with the exam and treatment;
- pregnant women
- patient who had ever received surgery or endoscopic treatment for biliopancreatic tract
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital.
Kaohsiung City, 386
Hoi Hung Chan, MD, PhD, +886-7-342-2121 ext. 2137, hoihungchan@gmail.com
Tzung Jiun Tsai, MD, +886-7-342-2121 ext. 2075, medfungi@gmail.com
About this study
Official title: Prospective Randomized Study Comparing the Effects of Endoscopic Sphincterotomy (EST) and Endoscopic Papillary Balloon Dilation (EPBD) in Patients With Acute Biliary Pancreatitis (ABP)
This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups.Moreover, the investigators compare the results obtained from the traditional bile/blood culture and metagenomics.
Read the detailed description
Early endoscopic retrograde choledocho pancreatogram with endoscopic sphincterotomy is suggested in patients with acute biliary pancreatitis to reduce complication and mortality. Retrospective study of the investigators' hospital showed that endoscopic papillary balloon dilation is safe in the treatment of acute biliary pancreatitis. However, there is no report in literature concerning about the prospective study comparing the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.
Moreover, the presence of infective microorganisms in the biliary and/or pancreatic ducts may play important role in both the onset and outcome of acute biliary pancreatitis. Blood or bile obtained via endoscopic means is another way to know the causative bacterium/bacteria.
However, it still need considerable period of time to get the result of the culture. Recently, next-generation sequencing technologies have been developed, which can facilitate the analysis of a large number of microorganisms in different environments and human body sites. 16S(a svedberg unit) ribosomal deoxyribonucleic acid sequence analysis and metagenomics are two effective DNA sequencing approaches, and both have been used to study uncultivated gut microbial communities.
Aims:
- To study the clinical effects of endoscopic sphincterotomy and endoscopic papillary balloon dilation in acute biliary pancreatitis.
- To compare the results obtained from the traditional bile/blood culture and metagenomics.
Methods: Beginning from Jan 2016, patients with age ≥ 20 years and acute biliary pancreatitis concomitant with either signs of acute cholangitis or bile duct obstruction will be enrolled in the study. Participants will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups. The treatment effects and safety of both groups will be compared. The primary endpoint is the relative successful rates of retrieval of common bile duct stones of both groups. The secondary endpoint is the frequency of use of mechanical lithotripter, other drainage procedures, complication and mortality, as well as the number of treatment sections.
Besides blood culture exam, bile will be aspirated by placing a single-use, 5-French, standard catheter (after guide-wire cannulation) into the bile duct before the injection of contrast agent for endoscopic retrograde cholangiopancreaticography. Approximately 10 mL of bile will be collected and transferred in a sterile tube. Half of the bile obtained will be transported to the microbiology laboratory in blood culture bottles and in an anaerobic transport system. Bacteria will be cultured and identified according to the standard protocol used in our clinical microbiology laboratory. Another half of the bile specimen will be sending for metagenomic study. Finally, investigators will try to compare the results obtained from the traditional bile culture /blood culture and metagenomics, and to understand the effects of infective microorganisms in the biliary and/or pancreatic ducts on the acute biliary pancreatitis. In addition, investigators want to find out the best means of early and accurate diagnosis of the pathogen responsible for the infection.
- Conditions
- Acute Biliary Pancreatitis
- Being tested
- Endoscopic papillary balloon dilation, Endoscopic sphincterotomy
- Keywords
- Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Metagenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic papillary balloon dilationProcedure or surgery
Also called EPBD
treatment of endoscopic papillary balloon dilation
Endoscopic sphincterotomyProcedure or surgery
Also called EST
treatment of endoscopic sphincterotomy
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic papillary balloon dilation | Experimental | For EPBD group, after selective cannulation of the common bile duct by the catheter, cholangiography will be performed to confirm the diagnosis of bile duct pathology. A 0.025-0.035-inch guidewire will then be inserted into the bile duct through the catheter. A dilating balloon (The controlled radial expansion (CRE) balloon dilation catheter, CRE balloon 5.5 cm (centimeter) in length, 1-1.2 cm/1.2-1.5 cm/1.5-2.0 cm in diameter) will be passed via the pre-positioned guidewire into the bile duct. Using fluoroscopic and endoscopic guidance, the balloon will be inflated with contrast medium up to the optimal size and duration (normally 5min (minutes)) after the waist on the balloon disappeared according to the patients' condition and tolerance. Receives: Procedure: Endoscopic papillary balloon dilation |
| Endoscopic sphincterotomy | Active comparator | For EST group,endoscopic sphincterotomy(EST) will be done as large as possible with a pull type sphincterotome (The TRUEtome, Biliary sphincterotomy sphincterotome, Single-use sphincterotome CleverCut2V)
Other interventions: surgical intervention, endoscopic stenting, percutaneous transhepatic cholangiogram with balloon dilation Receives: Procedure: Endoscopic sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete removal of common bile duct stones
Successful bile duct clearance was defined as complete if the final cholangiogram revealed no more filling defects.
Measured: one year
Secondary outcomes (1)
Evaluation of adverse events
Adverse events were recorded according to the definitions and grading systems from the consensus of an American Society of Gastrointestinal Endoscopy Workshop. (P. B. Cotton, G. M. Eisen, L. Aabakken et al., "A lexicon for endoscopic adverse events: report of an ASGE workshop," Gastrointestinal Endoscopy, vol. 71, no. 3, pp. 446-454, 2010.)
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Biliary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoi-Hung Chan, Kaohsiung Veterans General Hospital.
- Investigators
- Hoi Hung Chan, MD, PhD, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668081
- Sponsor's protocol ID
- VGHKS15-CT7-13
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Effects of Endoscopic Sphincterotomy (EST) and Endoscopic Papillary Balloon Dilation (EPBD) in Patients With Acute Biliary Pancreatitis (ABP)
- ClinicalTrials.gov ID
- NCT02668081
- Acronym / sponsor ID
- VGHKS15-CT7-13
- Conditions
- Acute Biliary Pancreatitis
- Keywords
- Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Metagenomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jan 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.
This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups.Moreover, the investigators compare the results obtained from the traditional bile/blood culture and metagenomics.
Detailed description
Early endoscopic retrograde choledocho pancreatogram with endoscopic sphincterotomy is suggested in patients with acute biliary pancreatitis to reduce complication and mortality. Retrospective study of the investigators' hospital showed that endoscopic papillary balloon dilation is safe in the treatment of acute biliary pancreatitis. However, there is no report in literature concerning about the prospective study comparing the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.
Moreover, the presence of infective microorganisms in the biliary and/or pancreatic ducts may play important role in both the onset and outcome of acute biliary pancreatitis. Blood or bile obtained via endoscopic means is another way to know the causative bacterium/bacteria.
However, it still need considerable period of time to get the result of the culture. Recently, next-generation sequencing technologies have been developed, which can facilitate the analysis of a large number of microorganisms in different environments and human body sites. 16S(a svedberg unit) ribosomal deoxyribonucleic acid sequence analysis and metagenomics are two effective DNA sequencing approaches, and both have been used to study uncultivated gut microbial communities.
Aims:
- To study the clinical effects of endoscopic sphincterotomy and endoscopic papillary balloon dilation in acute biliary pancreatitis.
- To compare the results obtained from the traditional bile/blood culture and metagenomics.
Methods: Beginning from Jan 2016, patients with age ≥ 20 years and acute biliary pancreatitis concomitant with either signs of acute cholangitis or bile duct obstruction will be enrolled in the study. Participants will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups. The treatment effects and safety of both groups will be compared. The primary endpoint is the relative successful rates of retrieval of common bile duct stones of both groups. The secondary endpoint is the frequency of use of mechanical lithotripter, other drainage procedures, complication and mortality, as well as the number of treatment sections.
Besides blood culture exam, bile will be aspirated by placing a single-use, 5-French, standard catheter (after guide-wire cannulation) into the bile duct before the injection of contrast agent for endoscopic retrograde cholangiopancreaticography. Approximately 10 mL of bile will be collected and transferred in a sterile tube. Half of the bile obtained will be transported to the microbiology laboratory in blood culture bottles and in an anaerobic transport system. Bacteria will be cultured and identified according to the standard protocol used in our clinical microbiology laboratory. Another half of the bile specimen will be sending for metagenomic study. Finally, investigators will try to compare the results obtained from the traditional bile culture /blood culture and metagenomics, and to understand the effects of infective microorganisms in the biliary and/or pancreatic ducts on the acute biliary pancreatitis. In addition, investigators want to find out the best means of early and accurate diagnosis of the pathogen responsible for the infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic papillary balloon dilation | Experimental | Procedure: Endoscopic papillary balloon dilationFor EPBD group, after selective cannulation of the common bile duct by the catheter, cholangiography will be performed to confirm the diagnosis of bile duct pathology. A 0.025-0.035-inch guidewire will then be inserted into the bile duct through the catheter. A dilating balloon (The controlled radial expansion (CRE) balloon dilation catheter, CRE balloon 5.5 cm (centimeter) in length, 1-1.2 cm/1.2-1.5 cm/1.5-2.0 cm in diameter) will be passed via the pre-positioned guidewire into the bile duct. Using fluoroscopic and endoscopic guidance, the balloon will be inflated with contrast medium up to the optimal size and duration (normally 5min (minutes)) after the waist on the balloon disappeared according to the patients' condition and tolerance. |
| Endoscopic sphincterotomy | Active comparator | Procedure: Endoscopic sphincterotomyFor EST group,endoscopic sphincterotomy(EST) will be done as large as possible with a pull type sphincterotome (The TRUEtome, Biliary sphincterotomy sphincterotome, Single-use sphincterotome CleverCut2V) Other interventions: surgical intervention, endoscopic stenting, percutaneous transhepatic cholangiogram with balloon dilation |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with acute gallstone pancreatitis and fulfill any two items from a to c, plus one item in d, and e:
- abdominal pain typical of pancreatitis;
- elevation of serum amylase and/or lipase up to three times above normal;
- imaging studies (abdominal ultrasound or abdominal computed tomography) showed evidence of pancreatitis
- common bile duct stones, acute cholangitis (Charcot's triad), total bilirubin (total bilirubin)> 4mg / dL, bile duct dilatation (diameter> 6mm with intact gallbladder, or> 10mm when the gallbladder has been removed) plus total bilirubin 1.8 ~ 4mg / dL;
Key exclusion criteria (6 listed)
- septic shock
- serious coagulopathy (international normalized ratio 1.5, partial thromboplastin time greater than twice that of control, platelet count <50 x 1000 / Cumm)
- malignant tumors of the biliary and pancreatic tract
- severe cardiovascular or mental illness which can not cooperate with the exam and treatment;
- pregnant women
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 |
|---|---|---|
| Endoscopic papillary balloon dilationAlso: EPBDtreatment of endoscopic papillary balloon dilation | Procedure or surgery | Endoscopic papillary balloon dilation |
| Endoscopic sphincterotomyAlso: ESTtreatment of endoscopic sphincterotomy | Procedure or surgery | Endoscopic sphincterotomy |
Primary outcome
Complete removal of common bile duct stones
Time frame: one year
Successful bile duct clearance was defined as complete if the final cholangiogram revealed no more filling defects.
1 secondary outcome
Evaluation of adverse events
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
Related trials for Acute Biliary Pancreatitis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Recruiting
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Chronic Pancreatitis, Chronic Pain
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Not yet recruiting
Outpatient Versus Inpatient Management of Mild Acute Pancreatitis
Acute Pancreatitis (AP), Biliary Pancreatitis
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.
Hoi Hung Chan, MD, PhD study chair
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic papillary balloon dilation and Endoscopic sphincterotomy in people with Acute Biliary Pancreatitis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 6 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 29 Jan 2016. 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 Taiwan. 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 Hoi Hung Chan, MD, PhD (+886-7-342-2121 ext. 2137, hoihungchan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete removal of common bile duct stones (time frame: one year). 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 29 Jan 2016.