PancreatitisNCT02971475
ESWL Versus ESWL and Endoscopic Treatment
A study testing extracorporeal shock wave lithotripsy, endoscopic drainage of the main pancreatic duct and Analgesics in people with Pancreatitis, run by Changhai Hospital at 2 sites in China.
Trial summary
The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- extracorporeal shock wave lithotripsy, endoscopic drainage of the main pancreatic duct and Analgesics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2016to Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
- at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
- no ERCP or ESWL carried out before admission
Who cannot join
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
- age below 18 years;
- pregnancy or lactation;
- refuse to write informed consent
Trial locations and contacts
2 sites in 1 country.
Zhao-shen Li contact
Zhuan Liao contact
China2 sites, 2 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Yang-Yang Qian, MD
- Recruiting
Shanghai Changhai Hospital
Shanghai
Zhao-shen Li, zhaoshen-li@hotmail.com
Zhuan Liao, liaozhuan@smmu.edu.cn
About this study
Official title: Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis
The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.
Read the detailed description
The combination mode of ESWL and ERCP is an established method of treatment of painful obstructive calcified chronic pancreatitis. However, the investigators notice that patients after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of the pancreatic pain.
So the investigators design such a prospective and randomized controlled trial. People diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random numbers.
ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions will be repeated if necessary, until stone fragmentation is obtained. Patients in the endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.
Follow-up will consists of telephone interview1 after treatment and clinical examination every 6 months thereafter. Data collected will include clinical presentation, ESWL, endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6 months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical examination.
- Conditions
- Pancreatitis
- Being tested
- extracorporeal shock wave lithotripsy, endoscopic drainage of the main pancreatic duct, Analgesics
- Keywords
- Extracorporeal Shock Wave lithotripsy(ESWL), Endoscopic Retrograde Cholangiopancreatography(ERCP), chronic pancreatitis, pain relief
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave lithotripsyProcedure or surgery
Also called ESWL
People in this group would be treated with ESWL only.
endoscopic drainage of the main pancreatic ductProcedure or surgery
Also called ERCP
People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
AnalgesicsDrug
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
| Study group | Role | What they receive |
|---|---|---|
| ESWL alone | Experimental | Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded. Receives: Procedure: extracorporeal shock wave lithotripsy; Drug: Analgesics |
| ESWL combined with ERCP | Active comparator | People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded. Receives: Procedure: endoscopic drainage of the main pancreatic duct; Drug: Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain score as accessed by izbichi pain score at 12 month
Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.
Measured: 12 months
Secondary outcomes (3)
exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit
Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, that is exocrine function normal, PEI develop, PEI resolve, PEI persist.
Measured: 12 months
clearance of pancreatic stones
Clearance of pancreatic stone is regarded as complete when clearance rate is more than 90%, partial is regarded as 50% to 90%, the rest is unsuccessful.
Measured: 12 months
decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971475
- Sponsor's protocol ID
- 20160801
- Status last verified
- May 2018
- First submitted
- 5 Sep 2016
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02971475
- Acronym / sponsor ID
- 20160801
- Conditions
- Pancreatitis
- Keywords
- Extracorporeal Shock Wave lithotripsy(ESWL), Endoscopic Retrograde Cholangiopancreatography(ERCP), chronic pancreatitis, pain relief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- 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 study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.
Detailed description
The combination mode of ESWL and ERCP is an established method of treatment of painful obstructive calcified chronic pancreatitis. However, the investigators notice that patients after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of the pancreatic pain.
So the investigators design such a prospective and randomized controlled trial. People diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random numbers.
ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions will be repeated if necessary, until stone fragmentation is obtained. Patients in the endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.
Follow-up will consists of telephone interview1 after treatment and clinical examination every 6 months thereafter. Data collected will include clinical presentation, ESWL, endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6 months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL alone | Experimental | Procedure: extracorporeal shock wave lithotripsy, Drug: AnalgesicsPatients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded. |
| ESWL combined with ERCP | Active comparator | Procedure: endoscopic drainage of the main pancreatic duct, Drug: AnalgesicsPeople in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
- at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
- no ERCP or ESWL carried out before admission
Key exclusion criteria (6 listed)
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
- age below 18 years;
- pregnancy or lactation;
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 |
|---|---|---|
| extracorporeal shock wave lithotripsyAlso: ESWLPeople in this group would be treated with ESWL only. | Procedure or surgery | ESWL alone |
| endoscopic drainage of the main pancreatic ductAlso: ERCPPeople in this group would be treated with ESWL followed be endoscopic drainage in 48 hours. | Procedure or surgery | ESWL combined with ERCP |
| AnalgesicsAnalgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed. | Drug | ESWL alone, ESWL combined with ERCP |
Primary outcome
Change from baseline pain score as accessed by izbichi pain score at 12 month
Time frame: 12 months
Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.
3 secondary outcomes
exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit
Time frame: 12 months
clearance of pancreatic stones
Time frame: 12 months
decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- 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.
Zhao-shen Li contact
Zhuan Liao contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shock wave lithotripsy, endoscopic drainage of the main pancreatic duct and Analgesics in people with Pancreatitis, run by Changhai Hospital at 2 sites 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 6 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhao-shen Li (zhaoshen-li@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain score as accessed by izbichi pain score at 12 month (time frame: 12 months). 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 1 Jun 2018.