Choledocholithiasis With Acute CholangitisNCT06349954
Effectiveness and Safety of Single-session Endoscopic Stone Extraction
A study testing single-session ERCP and two-session ERCP in people with Choledocholithiasis With Acute Cholangitis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Choledocholithiasis With Acute Cholangitis
- What is being tested?
- single-session ERCP and two-session ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 15 Jan 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old and ≤90 years old
- 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis
- 3. Imaging examination confirmed the presence of choledocholithiasis
Who cannot join
- 1. Common bile duct with benign or malignant stenosis
- 2. Changes in the anatomical structure of the stomach or duodenum
- 3. Patients with common biliary duct or pancreatic duct stent
- 4. Patients complicated with acute pancreatitis
- 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission
- 6. Patients with cardiac failure, respiratory failure or consciousness disorder can not tolerate endoscopic operation
- 7. Patients who have coagulation dysfunction or are taking anticoagulation and antiplate drugs
- 8. Imaging examination showed that the maximum diameter of choledocholithiasis was more than 1.5cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis
This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.
Read the detailed description
Acute cholangitis is an acute inflammation caused by obstruction of the bile duct, of which choledocholithiasis is the most common cause. Without timely removal of the obstruction or control of the infection, cholangitis can get worse and even become life-threatening. Therefore, timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis. Endoscopic retrograde cholangiography (ERCP) is used as the first-line treatment for choledocholithiasis-associated acute cholangitis. Previous guidelines recommended two-session endoscopic therapy. Endoscopic biliary drainage as the initial treatment, followed by endoscopic stone extraction after cholangitis improved. In recent years, studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment. Meanwhile, single-session endoscopic lithotomy can avoid the second ERCP intervention, which can relieve the pain of patients, reduce medical costs and shorten the length of hospital stay. However, there is still insufficient evidence on the effectiveness and safety of early single-session ERCP lithotomy. The aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis, so as to provide reference of clinical treatment.
In a prospective study, approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.
- Being tested
- single-session ERCP, two-session ERCP
- Keywords
- Acute Cholangitis, Endoscopic Retrograde Cholangiopancreatography, Choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-session ERCPProcedure or surgery
directly endoscopic stone extraction
two-session ERCPProcedure or surgery
early endoscopic drainage followed by endoscopic stone extraction
| Study group | Role | What they receive |
|---|---|---|
| single-session treatment group | Experimental | single-session ERCP Receives: Procedure: single-session ERCP |
| two-session treatment group | Experimental | two-session ERCP Receives: Procedure: two-session ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of complete stone removal
Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
Measured: during the operation
ERCP-related complication rate
The complications include pancreatitis, hemorrhage, perforation, pneumonia, etc. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination were measured.
Measured: from the operation to 1 month after the operation
Secondary outcomes (2)
Length of stay
Total time from admission to discharge.
Measured: perioperatively
Hospital expenses
Total expenses from admission to discharge.
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Apr 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledocholithiasis With Acute CholangitisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Model description
- All patients will be randomly allocated into single-session group or two-session group.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fujing Lv, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349954
- Sponsor's protocol ID
- BFHHZS20240064
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis
- ClinicalTrials.gov ID
- NCT06349954
- Acronym / sponsor ID
- BFHHZS20240064
- Keywords
- Acute Cholangitis, Endoscopic Retrograde Cholangiopancreatography, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 5 Apr 2024 (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 is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.
Detailed description
Acute cholangitis is an acute inflammation caused by obstruction of the bile duct, of which choledocholithiasis is the most common cause. Without timely removal of the obstruction or control of the infection, cholangitis can get worse and even become life-threatening. Therefore, timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis. Endoscopic retrograde cholangiography (ERCP) is used as the first-line treatment for choledocholithiasis-associated acute cholangitis. Previous guidelines recommended two-session endoscopic therapy. Endoscopic biliary drainage as the initial treatment, followed by endoscopic stone extraction after cholangitis improved. In recent years, studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment. Meanwhile, single-session endoscopic lithotomy can avoid the second ERCP intervention, which can relieve the pain of patients, reduce medical costs and shorten the length of hospital stay. However, there is still insufficient evidence on the effectiveness and safety of early single-session ERCP lithotomy. The aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis, so as to provide reference of clinical treatment.
In a prospective study, approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will be randomly allocated into single-session group or two-session group.
| Arm | Type | Receives |
|---|---|---|
| single-session treatment group | Experimental | Procedure: single-session ERCPsingle-session ERCP |
| two-session treatment group | Experimental | Procedure: two-session ERCPtwo-session ERCP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age ≥18 years old and ≤90 years old
- 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis
- 3. Imaging examination confirmed the presence of choledocholithiasis
Key exclusion criteria (8 listed)
- 1. Common bile duct with benign or malignant stenosis
- 2. Changes in the anatomical structure of the stomach or duodenum
- 3. Patients with common biliary duct or pancreatic duct stent
- 4. Patients complicated with acute pancreatitis
- 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission
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 |
|---|---|---|
| single-session ERCPdirectly endoscopic stone extraction | Procedure or surgery | single-session treatment group |
| two-session ERCPearly endoscopic drainage followed by endoscopic stone extraction | Procedure or surgery | two-session treatment group |
Primary outcome
Success rate of complete stone removal
Time frame: during the operation
Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
ERCP-related complication rate
Time frame: from the operation to 1 month after the operation
The complications include pancreatitis, hemorrhage, perforation, pneumonia, etc. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination were measured.
2 secondary outcomes
Length of stay
Time frame: perioperatively
Hospital expenses
Time frame: perioperatively
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 24 Jun 2025.
Related trials for Choledocholithiasis With Acute Cholangitis
Not yet recruitingObservational study
Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Choledocholithiasis, Choledocholithiasis With Acute Cholangitis
Not yet recruiting
Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis
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.
Fujing Lv, M.D. principal investigator
Beijing Friendship 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 single-session ERCP and two-session ERCP in people with Choledocholithiasis With Acute Cholangitis, run by Beijing Friendship 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 8 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 24 Jun 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?
Success rate of complete stone removal (time frame: during the operation). 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 24 Jun 2025.