Stone - BiliaryNCT03937037
Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
A study testing Saline irrigation in people with Stone - Biliary, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stone - Biliary
- What is being tested?
- Saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to 31 Dec 2022
- 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
- With ERCP indications
- With mechanical lithotripsy during operation
Who cannot join
- Unwillingness or inability to consent for the study
- Unstable vital signs
- Coagulation dysfunction (INR>1.5) and low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock
- Biliary-duodenal fistula confirmed during ERCP
- Pregnant women or breastfeeding
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: Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.
Read the detailed description
In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.
The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
- Conditions
- Stone - Biliary
- Being tested
- Saline irrigation
- Keywords
- ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation, Recurrence
- Medical subject headings
- Cholecystolithiasis, Gallstones, Cholangitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline irrigationProcedure or surgery
100ml saline irrigation after CBD stone removal with routine ERCP procedure
| Study group | Role | What they receive |
|---|---|---|
| Saline irrigation | Experimental | CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones. Receives: Procedure: Saline irrigation |
| None saline irrigation | No intervention | CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Recurrence of CBD Stones
Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
Measured: 3 years
Secondary outcomes (5)
Number of Participants with Cholangitis
Temperature should be more than 38 ℃, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal
Measured: 3 years
Number of Participants with Pancreatitis
Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after surgery, and there are also radiographic evidence suggesting the shape of pancreas has changed
Measured: 3 years
Number of Participants with Bleeding
Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl
Measured: 1 month
Number of Participants with Perforation
Was defined as the presence of air or contrast in the retroperitoneal space
Measured: 1 month
Procedure time of each case
From the moment the endoscope entered, to the moment withdraw the scope
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start10 May 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Stone - BiliaryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, MD,PhD, Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937037
- Sponsor's protocol ID
- Saline irrigation follow-up
- Status last verified
- Jan 2023
- First submitted
- 1 May 2019
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 29610513Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.
PubMed 19249039Lin Y, Yang M, Cao J, Zhang X, Mi N, Yang X, Wang H, Gao L, Bai M, Fu W, Li X, Yue P, Yuan J, Meng W, Leung JW. Saline irrigation for reducing the recurrence of common bile duct stones after lithotripsy: a randomized controlled trial. EClinicalMedicine. 2023 Apr 27;59:101978. doi: 10.1016/j.eclinm.2023.101978. eCollection 2023 May.
PubMed 37152367
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
- ClinicalTrials.gov ID
- NCT03937037
- Acronym / sponsor ID
- Saline irrigation follow-up
- Conditions
- Stone - Biliary
- Keywords
- ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 May 2019 (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 this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.
Detailed description
In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.
The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline irrigation | Experimental | Procedure: Saline irrigationCBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones. |
| None saline irrigation | No intervention | –CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- With ERCP indications
- With mechanical lithotripsy during operation
Key exclusion criteria (7 listed)
- Unwillingness or inability to consent for the study
- Unstable vital signs
- Coagulation dysfunction (INR>1.5) and low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, 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 |
|---|---|---|
| Saline irrigation100ml saline irrigation after CBD stone removal with routine ERCP procedure | Procedure or surgery | Saline irrigation |
Primary outcome
Number of Participants with Recurrence of CBD Stones
Time frame: 3 years
Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
5 secondary outcomes
Number of Participants with Cholangitis
Time frame: 3 years
Number of Participants with Pancreatitis
Time frame: 3 years
Number of Participants with Bleeding
Time frame: 1 month
Number of Participants with Perforation
Time frame: 1 month
Procedure time of each case
Time frame: 7 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 25 Jan 2023.
- 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 19249039Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.
- Derived from this study: PubMed 37152367Lin Y, Yang M, Cao J, Zhang X, Mi N, Yang X, Wang H, Gao L, Bai M, Fu W, Li X, Yue P, Yuan J, Meng W, Leung JW. Saline irrigation for reducing the recurrence of common bile duct stones after lithotripsy: a randomized controlled trial. EClinicalMedicine. 2023 Apr 27;59:101978. doi: 10.1016/j.eclinm.2023.101978. eCollection 2023 May.
- Individual participant dataSharing planned: No
Related trials for Stone - Biliary
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
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.
Wenbo Meng, MD,PhD principal investigator
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 Saline irrigation in people with Stone - Biliary, 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 7 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 25 Jan 2023. 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?
Number of Participants with Recurrence of CBD Stones (time frame: 3 years). 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 NCT03937037, 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 25 Jan 2023.