Cholangitis; CholedocholithiasisERCPNCT03754491
The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis
A study testing One stage treatment for mild and moderate cholangitis with choledocholithiasis in people with Cholangitis; Choledocholithiasis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangitis; Choledocholithiasis
- What is being tested?
- One stage treatment for mild and moderate cholangitis with choledocholithiasis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 31 Mar 2020
- 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
- naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
Who cannot join
- procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
- stenosis of the pyloric ring ;
- tumor-related obstruction;
- failure to locate the papilla ;
- active peptic ulcer bleeding ;
- intolerance due to inadequate sedation
- CBD sludge;
- non-naïve papilla in ERCP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.
Read the detailed description
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.
- Conditions
- Cholangitis; Choledocholithiasis
- Being tested
- One stage treatment for mild and moderate cholangitis with choledocholithiasis
- Keywords
- Acute cholangitis, choledocholithiasis, ERCP, One-stage treatment
- Medical subject headings
- Cholangitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One stage treatment for mild and moderate cholangitis with choledocholithiasisBehavioural
one stage of stone removal in mild or moderate cholangitis.
| Study group | Role | What they receive |
|---|---|---|
| One stage stone removal in mild cholangitis | Experimental | one-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history Receives: Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis |
| One stage stone removal in moderate cholangitis | Experimental | one-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history Receives: Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post ERCP pancreatitis
Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain
Measured: After ERCP, an average of 7 days
Bowel perforation
Participants with sign of bowel perforation after ERCP
Measured: After ERCP, an average of 7 days
Papillary bleeding
Participants with papillary bleeding after ERCP
Measured: After ERCP, an average of 7 days
Success rate of stone removal
Complete bile duct stone clearance
Measured: an average of 14 days.
Cost of hospitalization
Total cost in two individual groups in hospitalization.
Measured: From emergent department to the timing of being discharged, and an average of 30 days
Secondary outcomes (1)
Mortality
Mortality during and after discharged
Measured: an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Oct 2018
- Primary completion14 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholangitis; CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIH-MING LIANG, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754491
- Sponsor's protocol ID
- gimy54861439
- Acronym
- ERCP
- Status last verified
- Feb 2020
- First submitted
- 15 Oct 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.
PubMed 23307003Eto K, Kawakami H, Haba S, Yamato H, Okuda T, Yane K, Hayashi T, Ehira N, Onodera M, Matsumoto R, Matsubara Y, Takagi T, Sakamoto N; Hokkaido Interventional EUS/ERCP study (HONEST) group. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial. J Hepatobiliary Pancreat Sci. 2015 Dec;22(12):825-30. doi: 10.1002/jhbp.296. Epub 2015 Nov 25.
PubMed 26510180Liang CM, Chiu YC, Lu LS, Wu CK, Sou FM, Chiu SM, Lee YC, Huang PY, Chuah SK, Kuo CM. Early and Direct Endoscopic Stone Removal in the Moderate Grade of Acute Cholangitis with Choledocholithiasis Was Safe and Effective: A Prospective Study. Life (Basel). 2022 Nov 30;12(12):2000. doi: 10.3390/life12122000.
PubMed 36556365
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan
- ClinicalTrials.gov ID
- NCT03754491
- Acronym / sponsor ID
- ERCP / gimy54861439
- Conditions
- Cholangitis; Choledocholithiasis
- Keywords
- Acute cholangitis, choledocholithiasis, ERCP, One-stage treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 27 Nov 2018 (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.
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.
Detailed description
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
| Arm | Type | Receives |
|---|---|---|
| One stage stone removal in mild cholangitis | Experimental | Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasisone-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history |
| One stage stone removal in moderate cholangitis | Experimental | Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasisone-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
Key exclusion criteria (8 listed)
- procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
- stenosis of the pyloric ring ;
- tumor-related obstruction;
- failure to locate the papilla ;
- active peptic ulcer bleeding ;
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 |
|---|---|---|
| One stage treatment for mild and moderate cholangitis with choledocholithiasisone stage of stone removal in mild or moderate cholangitis. | Behavioural | One stage stone removal in mild cholangitis, One stage stone removal in moderate cholangitis |
Primary outcome
Post ERCP pancreatitis
Time frame: After ERCP, an average of 7 days
Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain
Bowel perforation
Time frame: After ERCP, an average of 7 days
Participants with sign of bowel perforation after ERCP
Papillary bleeding
Time frame: After ERCP, an average of 7 days
Participants with papillary bleeding after ERCP
Success rate of stone removal
Time frame: an average of 14 days.
Complete bile duct stone clearance
Cost of hospitalization
Time frame: From emergent department to the timing of being discharged, and an average of 30 days
Total cost in two individual groups in hospitalization.
1 secondary outcome
Mortality
Time frame: an average of 30 days
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 8 Apr 2021.
- Results publication: PubMed 23307003Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.
- Results publication: PubMed 26510180Eto K, Kawakami H, Haba S, Yamato H, Okuda T, Yane K, Hayashi T, Ehira N, Onodera M, Matsumoto R, Matsubara Y, Takagi T, Sakamoto N; Hokkaido Interventional EUS/ERCP study (HONEST) group. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial. J Hepatobiliary Pancreat Sci. 2015 Dec;22(12):825-30. doi: 10.1002/jhbp.296. Epub 2015 Nov 25.
- Derived from this study: PubMed 36556365Liang CM, Chiu YC, Lu LS, Wu CK, Sou FM, Chiu SM, Lee YC, Huang PY, Chuah SK, Kuo CM. Early and Direct Endoscopic Stone Removal in the Moderate Grade of Acute Cholangitis with Choledocholithiasis Was Safe and Effective: A Prospective Study. Life (Basel). 2022 Nov 30;12(12):2000. doi: 10.3390/life12122000.
- 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.
CHIH-MING LIANG, MD principal investigator
Chang Gung Memorial 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 One stage treatment for mild and moderate cholangitis with choledocholithiasis in people with Cholangitis; Choledocholithiasis, run by Chang Gung Memorial 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 1 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 8 Apr 2021. 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?
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?
Post ERCP pancreatitis (time frame: After ERCP, an average of 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754491, which also lists 3 linked publications.
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 8 Apr 2021.