Choledocholithiasis With Acute CholangitisNCT06327126
Efficacy and Safety of Single-session Endoscopic Stone Extraction
An observational study of Choledocholithiasis With Acute Cholangitis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis With Acute Cholangitis
- What is being tested?
- two-session ERCP and single-session ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 563 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2024
- Phase
- Observational
- 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
Study population: Patients who diagnosed with acute cholangitis associated with choledocholithiasis underwent single-session stone extraction or two-session treatment involving stone removal after drainage at Beijing Friendship Hospital.
Who may be able to join
- Age ≥18 years old
- Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of acute cholangitis
- Imaging examination confirmed the presence of choledocholithiasis
- Patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage
Who cannot join
- Common bile duct with benign or malignant stenosis
- Changes in the anatomical structure of the stomach or duodenum
- Patients complicated with severe acute pancreatitis
- Patients who underwent endoscopic intervention before admission
- Patients received percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions besides endoscopic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Single-session Endoscopic Stone Extraction for Treating Acute Cholangitis Accompanied With Choledocholithiasis
This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage 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 retrospective analysis, approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital were studied. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.
- Being tested
- two-session ERCP, single-session ERCP
- Keywords
- Choledocholithiasis, Acute Cholangitis, Endoscopic Retrograde Cholangiopancreatography
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-session ERCPProcedure or surgery
early endoscopic drainage followed by endoscopic stone extraction
single-session ERCPProcedure or surgery
directly endoscopic stone extraction
| Study group | Role | What they receive |
|---|---|---|
| two-session treatment group | two-session ERCP Receives: Procedure: two-session ERCP | |
| single-session treatment group | single-session ERCP Receives: Procedure: single-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 posted25 Mar 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 Jul 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 563 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
- NCT06327126
- Sponsor's protocol ID
- BFHHZS20240001
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single-session Endoscopic Stone Extraction for Treating Acute Cholangitis Accompanied With Choledocholithiasis
- ClinicalTrials.gov ID
- NCT06327126
- Acronym / sponsor ID
- BFHHZS20240001
- Keywords
- Choledocholithiasis, Acute Cholangitis, Endoscopic Retrograde Cholangiopancreatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 25 Mar 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 retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage 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 retrospective analysis, approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital were studied. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two-session treatment group | – | Procedure: two-session ERCPtwo-session ERCP |
| single-session treatment group | – | Procedure: single-session ERCPsingle-session ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed with acute cholangitis associated with choledocholithiasis underwent single-session stone extraction or two-session treatment involving stone removal after drainage at Beijing Friendship Hospital.
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of acute cholangitis
- Imaging examination confirmed the presence of choledocholithiasis
- Patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage
Key exclusion criteria (5 listed)
- Common bile duct with benign or malignant stenosis
- Changes in the anatomical structure of the stomach or duodenum
- Patients complicated with severe acute pancreatitis
- Patients who underwent endoscopic intervention before admission
- Patients received percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions besides endoscopic treatment
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 |
|---|---|---|
| two-session ERCPearly endoscopic drainage followed by endoscopic stone extraction | Procedure or surgery | two-session treatment group |
| single-session ERCPdirectly endoscopic stone extraction | Procedure or surgery | single-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 17 Jul 2024.
- 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.
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?
An observational study of 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 4 inclusion and 5 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 17 Jul 2024. 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 17 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.