Pancreatitis, ChronicNCT05326542
Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP
A study testing ESWL and ERCP and LL and ERCP in people with Pancreatitis, Chronic and Pancreatic Duct Stone, run by Changhai Hospital at 1 site in China.
Trial summary
This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Chronic, Pancreatic Duct Stone
- What is being tested?
- ESWL and ERCP and LL and ERCP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
- at least one stone (>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
- dilation of the proximal pancreatic duct.
Who cannot join
- history of ERCP or ESWL treatment;
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- pancreatic pseudocyst with a diameter >4cm;
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
- acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
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- coagulation dysfunction (INR≥1.5 or platelet count≤50×10^9/L);
- pregnant or breastfeeding women;
- patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital
Shanghai, 200433
Liang-hao Hu, MD, +86-13817593520, lianghao-hu@smmu.edu.cn
Zhao-shen Li, MD, +86-13901960921, zhaoshen-li@hotmail.com
About this study
Official title: ESWL Combined With ERCP and Laser Lithotripsy Combined With ERCP In Treatment of Pancreatic Duct Stones With Chronic Pancreatitis: a Randomized Controlled Trial
This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.
Read the detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic Retrograde Cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones by using basket and/or balloon catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL).
ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone.
In view of the fact that there is no relevant research comparing the overall efficacy of ESWL combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for PD stones. This research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.
- Conditions
- Pancreatitis, Chronic, Pancreatic Duct Stone
- Being tested
- ESWL and ERCP, LL and ERCP
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL and ERCPProcedure or surgery
First, ESWL will be used for lithotripsy, and then ERCP will be performed to clear the stones after lithotripsy.
LL and ERCPProcedure or surgery
After establishing the working channel under ERCP, the stone will be crushed with a laser lithotripter, and then ERCP will clear the stones after lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| ESWL and ERCP | Experimental | The patients will receive intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP will be greater than 48h. ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary. Receives: Procedure: ESWL and ERCP |
| LL and ERCP | Active comparator | ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, laser lithotripsy will be performed. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary. Receives: Procedure: LL and ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success rates
Technical success rates refer to the successful completion of standard procedures or the occurrence of complete spontaneous stone removal.
Measured: during ERCP procedure
clearance rates of pancreatic duct stones
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively.
Measured: during ERCP procedure
Secondary outcomes (3)
time taken to completely clear the stone
The time taken to completely clear the stones.
Measured: during ESWL and ERCP procedure
postoperative complications
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.
Measured: 30 days after ERCP procedure
success rates of pancreatic duct decompression
Successful removal of pancreatic duct obstruction factors by clearing stones and/or placing pancreatic duct stents/nasopancreatic catheters.
Measured: during ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startSep 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326542
- Sponsor's protocol ID
- ECLIPSE20220312
- Status last verified
- Sep 2022
- First submitted
- 6 Apr 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
PubMed 31238312
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESWL Combined With ERCP and Laser Lithotripsy Combined With ERCP In Treatment of Pancreatic Duct Stones With Chronic Pancreatitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05326542
- Acronym / sponsor ID
- ECLIPSE20220312
- Conditions
- Pancreatitis, Chronic, Pancreatic Duct Stone
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Apr 2022 (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 study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.
Detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic Retrograde Cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones by using basket and/or balloon catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL).
ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone.
In view of the fact that there is no relevant research comparing the overall efficacy of ESWL combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for PD stones. This research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL and ERCP | Experimental | Procedure: ESWL and ERCPThe patients will receive intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP will be greater than 48h. ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary. |
| LL and ERCP | Active comparator | Procedure: LL and ERCPERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, laser lithotripsy will be performed. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
- at least one stone (>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
- dilation of the proximal pancreatic duct.
Key exclusion criteria (9 listed)
- history of ERCP or ESWL treatment;
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- pancreatic pseudocyst with a diameter >4cm;
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
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 |
|---|---|---|
| ESWL and ERCPFirst, ESWL will be used for lithotripsy, and then ERCP will be performed to clear the stones after lithotripsy. | Procedure or surgery | ESWL and ERCP |
| LL and ERCPAfter establishing the working channel under ERCP, the stone will be crushed with a laser lithotripter, and then ERCP will clear the stones after lithotripsy. | Procedure or surgery | LL and ERCP |
Primary outcome
technical success rates
Time frame: during ERCP procedure
Technical success rates refer to the successful completion of standard procedures or the occurrence of complete spontaneous stone removal.
clearance rates of pancreatic duct stones
Time frame: during ERCP procedure
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively.
3 secondary outcomes
time taken to completely clear the stone
Time frame: during ESWL and ERCP procedure
postoperative complications
Time frame: 30 days after ERCP procedure
success rates of pancreatic duct decompression
Time frame: during ERCP procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 31238312Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
- 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.
Liang-hao Hu, MD principal investigator
Changhai 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 ESWL and ERCP and LL and ERCP in people with Pancreatitis, Chronic and Pancreatic Duct Stone, run by Changhai 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 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang-hao Hu, MD (+86-13817593520, ianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success rates (time frame: during ERCP procedure). 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?
On the ClinicalTrials.gov record for NCT05326542, which also lists 1 linked publication.
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 Sep 2022.