Stone ClearanceNCT03701009
Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing CBD stone removal via lithotripsy, Saline 50ml and Saline +50ml in people with Stone Clearance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stone Clearance
- What is being tested?
- CBD stone removal via lithotripsy, Saline 50ml and Saline +50ml
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to 1 Jul 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
- ERCP common bile duct stone patients were able to provide written informed consent;
- Size of stone large than 1.2 cm.
Who cannot join
- Unwillingness or inability to consent for the study;
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;
- Previous ERCP;
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock;
- Biliary-duodenal fistula confirmed during ERCP;
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- Pregnant women or breastfeeding;
- Presence of intrahepatic duct stone;
- Malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
Read the detailed description
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
- Conditions
- Stone Clearance
- Being tested
- CBD stone removal via lithotripsy, Saline 50ml, Saline +50ml
- Keywords
- ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation
- Medical subject headings
- Gallstones, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD stone removal via lithotripsyProcedure or surgery
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
Saline 50mlProcedure or surgery
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
Saline +50mlProcedure or surgery
If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.
| Study group | Role | What they receive |
|---|---|---|
| Stone removal (Saline 50ml each time) | Other | After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass. Receives: Procedure: CBD stone removal via lithotripsy; Procedure: Saline 50ml; Procedure: Saline +50ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone fragments clearance
Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
Measured: 3 months
Secondary outcomes (5)
Post-ERCP cholangitis
Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections.
Measured: 3 months
Bleeding
Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl.
Measured: 3 months
Post-ERCP pancreatitis
Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure.
Measured: 3 months
Perforation
Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
Measured: 3 months
The procedure time
Was defined as the sum of times of all processes of endoscopic procedure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Oct 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stone ClearanceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xun Li, MD,PhD, Study director, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701009
- Sponsor's protocol ID
- Saline irrigation in ERCP
- Status last verified
- Jul 2020
- First submitted
- 6 Oct 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.
PubMed 29610513Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.
PubMed 21737076
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
- ClinicalTrials.gov ID
- NCT03701009
- Acronym / sponsor ID
- Saline irrigation in ERCP
- Conditions
- Stone Clearance
- Keywords
- ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 9 Oct 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.
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
Detailed description
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stone removal (Saline 50ml each time) | Other | Procedure: CBD stone removal via lithotripsy, Procedure: Saline 50ml, Procedure: Saline +50mlAfter CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ERCP common bile duct stone patients were able to provide written informed consent;
- Size of stone large than 1.2 cm.
Key exclusion criteria (9 listed)
- Unwillingness or inability to consent for the study;
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;
- Previous ERCP;
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock;
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 |
|---|---|---|
| CBD stone removal via lithotripsyHold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored. | Procedure or surgery | Stone removal (Saline 50ml each time) |
| Saline 50mlIf not clean, intermittent saline irrigation 50ml, and Spyglass explored second time. | Procedure or surgery | Stone removal (Saline 50ml each time) |
| Saline +50mlIf still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance. | Procedure or surgery | Stone removal (Saline 50ml each time) |
Primary outcome
Stone fragments clearance
Time frame: 3 months
Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
5 secondary outcomes
Post-ERCP cholangitis
Time frame: 3 months
Bleeding
Time frame: 3 months
Post-ERCP pancreatitis
Time frame: 3 months
Perforation
Time frame: 3 months
The procedure time
Time frame: 3 months
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 14 Jul 2020.
- Background: PubMed 29610513Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.
- Background: PubMed 21737076Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.
- 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.
Xun Li, MD,PhD study director
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD stone removal via lithotripsy, Saline 50ml and Saline +50ml in people with Stone Clearance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 2 inclusion and 9 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 14 Jul 2020. 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?
Stone fragments clearance (time frame: 3 months). 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 NCT03701009, which also lists 2 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 14 Jul 2020.