Severe Acute CholangitisNCT07064980
ERCP Versus PTBD for Severe Acute Cholangitis Caused by Bile Duct Stones
A study testing Endoscopic Retrograde Cholangiopancreatography and Percutaneous Transhepatic Biliary Drainage in people with Severe Acute Cholangitis, run by Wuhan Integrated Traditional Chinese and Western Medicine Hospital at 1 site in China.
Trial summary
This study is a prospective, randomized controlled trial designed to compare the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) with percutaneous transhepatic biliary drainage (PTBD) for the treatment of severe acute cholangitis caused by common bile duct stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Cholangitis
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography and Percutaneous Transhepatic Biliary Drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met the diagnostic criteria for acute cholangitis according to the Tokyo Guidelines 2018 (TG18), and were diagnosed through physical examination, ultrasound, CT, or MRCP showing common bile duct stones as the cause of obstruction.
- Body temperature <36°C or >38°C.
- Presence of jaundice or signs of organ dysfunction (e.g., hypotension responsive to fluids for Grade II, or requiring vasopressors for Grade III, altered mental status, etc.).
- Patients who signed informed consent.
Who cannot join
- Patients with concurrent diseases such as gastric perforation or active gastrointestinal bleeding unrelated to cholangitis.
- Patients with acute pancreatitis as the primary diagnosis.
- Patients with serious primary diseases in the heart, brain, lungs, kidneys, hematopoietic, or nervous systems contraindicating either procedure.
- Pregnant or breastfeeding women.
- Patients with cognitive dysfunction unable to provide consent.
- Known pancreatobiliary malignancy as the cause of obstruction.
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- Severe liver cirrhosis (Child-Pugh C) or liver atrophy.
- Patients with severe systemic primary diseases, who could not tolerate the anesthesia or procedure.
- Patients with mental disorders, hematologic diseases (e.g., severe coagulopathy uncorrectable pre-procedure), autoimmune diseases directly impacting biliary system, or those using high-dose corticosteroids affecting inflammatory markers.
- Patients participating in other clinical drug trials.
- Previous ERCP or PTBD for the current episode of cholangitis.
Trial locations and contacts
1 site in 1 country.
China1 site
Wuhan No.1 Hospital (Wuhan Hospital of Traditional Chinese & Western Medicine)
Wuhan, Hubei, 430030
About this study
Official title: Analysis of the Effectiveness and Safety of Endoscopic Retrograde Cholangiopancreatography Versus Percutaneous Transhepatic Biliary Drainage in Severe Acute Cholangitis Caused by Common Bile Duct Stones
This study is a prospective, randomized controlled trial designed to compare the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) with percutaneous transhepatic biliary drainage (PTBD) for the treatment of severe acute cholangitis caused by common bile duct stones. The primary goal is to determine which emergency drainage procedure leads to faster patient recovery, specifically by evaluating the length of hospital stay, without increasing complication rates.
Read the detailed description
Severe acute cholangitis (AC) due to common bile duct stones is a life-threatening condition requiring urgent biliary decompression. While both ERCP and PTBD are established minimally invasive options, the optimal choice remains under discussion. This single-center, prospective, randomized controlled trial was conducted to compare these two interventions. A total of 126 patients with severe AC (Tokyo Guidelines 2018 Grade II or III) were randomized to either the ERCP group (n=63) or the PTBD group (n=63). Randomization was performed using a computer-generated sequence with concealed allocation. While operators could not be blinded, outcome assessors and data analysts were. The study hypothesis is that ERCP, as a more direct route for potential stone removal and drainage, may facilitate a quicker overall recovery compared to PTBD. The trial evaluates procedural outcomes, recovery metrics, therapeutic efficacy, inflammatory markers, and safety profiles to provide evidence for clinical decision-making.
- Conditions
- Severe Acute Cholangitis
- Being tested
- Endoscopic Retrograde Cholangiopancreatography, Percutaneous Transhepatic Biliary Drainage
- Keywords
- Endoscopic retrograde cholangiopancreatography, Percutaneous transhepatic biliary drainage, Severe Acute Cholangitis, Common Bile Duct Stones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
Performed under intravenous anesthesia. A duodenoscope was advanced to the major duodenal papilla. After cannulation and cholangiography, purulent bile was aspirated. Biliary sphincterotomy was performed in most patients (95.2%), followed by stone extraction using a balloon catheter or basket. A 7-10 Fr nasobiliary tube was placed for drainage in all patients. Prophylactic rectal indomethacin (100mg) was also administered.
Percutaneous Transhepatic Biliary DrainageProcedure or surgery
Performed under general anesthesia with endotracheal intubation and ultrasound guidance. An 18G needle was used to puncture a dilated intrahepatic bile duct. After guidewire placement, an 8-10 Fr drainage catheter was inserted for either internal-external drainage (if the guidewire could pass into the duodenum) or purely external biliary drainage.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (ERCP) | Experimental | Patients assigned to this arm underwent endoscopic retrograde cholangiopancreatography (ERCP). After intravenous anesthesia, a duodenoscope was advanced to the major duodenal papilla. The bile duct was cannulated, and common bile duct stones were extracted using a basket or balloon, typically following a biliary sphincterotomy. A nasobiliary tube was placed for drainage. All patients in this group received prophylactic rectal indomethacin (100mg). Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography |
| Active Comparator Group (PTBD) | Active comparator | Patients assigned to this arm underwent percutaneous transhepatic biliary drainage (PTBD). Under general anesthesia and ultrasound guidance, a dilated intrahepatic bile duct was punctured. A guidewire was passed into the biliary system, followed by the placement of an 8-10 Fr drainage catheter for either internal-external or purely external biliary drainage. Receives: Procedure: Percutaneous Transhepatic Biliary Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
The total number of days from hospital admission to discharge.
Measured: At hospital discharge (up to approximately 3-4 weeks post-procedure).
Secondary outcomes (7)
Time to First Ambulation
Time in days from the procedure until the patient is first able to walk.
Measured: From date of procedure until hospital discharge (estimated maximum of 4 weeks).
Procedure Time
Time in minutes from scope insertion/skin puncture to the end of drainage placement.
Measured: Measured intraoperatively
Time to Return of Bowel Function
Time in hours or days from the procedure until the first flatus or bowel movement.
Measured: From date of procedure until hospital discharge (estimated maximum of 4 weeks).
Change in Inflammatory Markers
Change from baseline in serum levels of Interleukin-6 (IL-6), Interleukin-1 (IL-1), Tumor Necrosis Factor-alpha (TNF-α), and C-reactive protein (CRP).
Measured: Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.
Change in Pain Intensity
Change from baseline in pain severity assessed using the Visual Analog Scale (VAS), scored 0-10.
Measured: Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.
Therapeutic Efficacy
Assessed as Significant Effect, Effective, or Ineffective based on resolution of biliary obstruction and clinical symptoms within 24 hours. The total effective rate is calculated as (Significant + Effective) / Total cases.
Measured: Assessed at 24 hours post-procedure.
Incidence of Complications
Number of participants experiencing adverse events, including post-ERCP pancreatitis, abdominal infection, gastrointestinal bleeding, bile leakage, liver damage, and procedure-specific complications.
Measured: up to 3 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 May 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute CholangitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Zhu, Wuhan Integrated Traditional Chinese and Western Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064980
- Sponsor's protocol ID
- IRB-2021-KY027
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness and Safety of Endoscopic Retrograde Cholangiopancreatography Versus Percutaneous Transhepatic Biliary Drainage in Severe Acute Cholangitis Caused by Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT07064980
- Acronym / sponsor ID
- IRB-2021-KY027
- Conditions
- Severe Acute Cholangitis
- Keywords
- Endoscopic retrograde cholangiopancreatography, Percutaneous transhepatic biliary drainage, Severe Acute Cholangitis, Common Bile Duct Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 15 Jul 2025 (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.
This study is a prospective, randomized controlled trial designed to compare the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) with percutaneous transhepatic biliary drainage (PTBD) for the treatment of severe acute cholangitis caused by common bile duct stones. The primary goal is to determine which emergency drainage procedure leads to faster patient recovery, specifically by evaluating the length of hospital stay, without increasing complication rates.
Detailed description
Severe acute cholangitis (AC) due to common bile duct stones is a life-threatening condition requiring urgent biliary decompression. While both ERCP and PTBD are established minimally invasive options, the optimal choice remains under discussion. This single-center, prospective, randomized controlled trial was conducted to compare these two interventions. A total of 126 patients with severe AC (Tokyo Guidelines 2018 Grade II or III) were randomized to either the ERCP group (n=63) or the PTBD group (n=63). Randomization was performed using a computer-generated sequence with concealed allocation. While operators could not be blinded, outcome assessors and data analysts were. The study hypothesis is that ERCP, as a more direct route for potential stone removal and drainage, may facilitate a quicker overall recovery compared to PTBD. The trial evaluates procedural outcomes, recovery metrics, therapeutic efficacy, inflammatory markers, and safety profiles to provide evidence for clinical decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (ERCP) | Experimental | Procedure: Endoscopic Retrograde CholangiopancreatographyPatients assigned to this arm underwent endoscopic retrograde cholangiopancreatography (ERCP). After intravenous anesthesia, a duodenoscope was advanced to the major duodenal papilla. The bile duct was cannulated, and common bile duct stones were extracted using a basket or balloon, typically following a biliary sphincterotomy. A nasobiliary tube was placed for drainage. All patients in this group received prophylactic rectal indomethacin (100mg). |
| Active Comparator Group (PTBD) | Active comparator | Procedure: Percutaneous Transhepatic Biliary DrainagePatients assigned to this arm underwent percutaneous transhepatic biliary drainage (PTBD). Under general anesthesia and ultrasound guidance, a dilated intrahepatic bile duct was punctured. A guidewire was passed into the biliary system, followed by the placement of an 8-10 Fr drainage catheter for either internal-external or purely external biliary drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who met the diagnostic criteria for acute cholangitis according to the Tokyo Guidelines 2018 (TG18), and were diagnosed through physical examination, ultrasound, CT, or MRCP showing common bile duct stones as the cause of obstruction.
- Body temperature <36°C or >38°C.
- Presence of jaundice or signs of organ dysfunction (e.g., hypotension responsive to fluids for Grade II, or requiring vasopressors for Grade III, altered mental status, etc.).
- Patients who signed informed consent.
Key exclusion criteria (11 listed)
- Patients with concurrent diseases such as gastric perforation or active gastrointestinal bleeding unrelated to cholangitis.
- Patients with acute pancreatitis as the primary diagnosis.
- Patients with serious primary diseases in the heart, brain, lungs, kidneys, hematopoietic, or nervous systems contraindicating either procedure.
- Pregnant or breastfeeding women.
- Patients with cognitive dysfunction unable to provide consent.
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 Retrograde CholangiopancreatographyPerformed under intravenous anesthesia. A duodenoscope was advanced to the major duodenal papilla. After cannulation and cholangiography, purulent bile was aspirated. Biliary sphincterotomy was performed in most patients (95.2%), followed by stone extraction using a balloon catheter or basket. A 7-10 Fr nasobiliary tube was placed for drainage in all patients. Prophylactic rectal indomethacin (100mg) was also administered. | Procedure or surgery | Experimental Group (ERCP) |
| Percutaneous Transhepatic Biliary DrainagePerformed under general anesthesia with endotracheal intubation and ultrasound guidance. An 18G needle was used to puncture a dilated intrahepatic bile duct. After guidewire placement, an 8-10 Fr drainage catheter was inserted for either internal-external drainage (if the guidewire could pass into the duodenum) or purely external biliary drainage. | Procedure or surgery | Active Comparator Group (PTBD) |
Primary outcome
Length of Hospital Stay
Time frame: At hospital discharge (up to approximately 3-4 weeks post-procedure).
The total number of days from hospital admission to discharge.
7 secondary outcomes
Time to First Ambulation
Time frame: From date of procedure until hospital discharge (estimated maximum of 4 weeks).
Procedure Time
Time frame: Measured intraoperatively
Time to Return of Bowel Function
Time frame: From date of procedure until hospital discharge (estimated maximum of 4 weeks).
Change in Inflammatory Markers
Time frame: Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.
Change in Pain Intensity
Time frame: Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.
Therapeutic Efficacy
Time frame: Assessed at 24 hours post-procedure.
Incidence of Complications
Time frame: up to 3 months post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Retrograde Cholangiopancreatography and Percutaneous Transhepatic Biliary Drainage in people with Severe Acute Cholangitis, run by Wuhan Integrated Traditional Chinese and Western Medicine 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 15 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: At hospital discharge (up to approximately 3-4 weeks post-procedure).). 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 15 Jul 2025.