Chronic PancreatitisNCT04628273
Treatment Strategy of Pancreatic Radiolucent Stone
An observational study of Chronic Pancreatitis, run by Changhai Hospital.
Trial summary
Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 30 Jan 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CP patients with pancreatic radiolucent stones large than 5mm from March 2011 to December 2018 admitted to Changhai Hospital were included in this study. Patients with pancreatic radiopaque stones large than 5mm were matched as the control group, with a ratio of 1:2 according to admission time. CP was diagnosed primarily based on the Asia-Pacific consensus. Pancreatic radiopaque stone was diagnosed by CT scan while radiolucent stone by MRI or MRCP.
Who may be able to join
- Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm
Who cannot join
- Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis
About this study
Official title: A Prospective Cohort Study of Large Pancreatic Radiolucent Stone
Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.
Read the detailed description
- Treatment strategy of CP patients with large pancreatic stone：
- . For patients with large radiolucent stone，ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent.
- . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended.
- A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time.
- The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.
- Conditions
- Chronic Pancreatitis
- Being tested
- encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave 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.
encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| radiolucent stone group | Not described Receives: Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy | |
| radiopaque stone group | Not described Receives: Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of pain relief
Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score > 10 after a decrease of > 50%)
Measured: after treatment to 2020-01-30
Secondary outcomes (2)
rate of stone clearance
Rate of stone clearance is evaluated by ERCP as follows: a) complete clearance as clearance of > 90% of stone volume; b) partial clearance as clearance of 50%-90% of stone volume; c) unsuccessful clearance as less than 50% clearance of stone volume
Measured: during ERCP procedure
score of life quality
Quality of life score was a subjective evaluation index of patient which ranged from 0 to 100, with higher score indicating a better quality of life
Measured: after treatment to 2020-01-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Mar 2011
- Primary completion30 Dec 2018
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628273
- Sponsor's protocol ID
- Large PRS
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tandan M, Reddy DN, Santosh D, Vinod K, Ramchandani M, Rajesh G, Rama K, Lakhtakia S, Banerjee R, Pratap N, Venkat Rao G. Extracorporeal shock wave lithotripsy and endotherapy for pancreatic calculi-a large single center experience. Indian J Gastroenterol. 2010 Jul;29(4):143-8. doi: 10.1007/s12664-010-0035-y. Epub 2010 Aug 18.
PubMed 20717860Neuhaus H. Fragmentation of pancreatic stones by extracorporeal shock wave lithotripsy. Endoscopy. 1991 May;23(3):161-5. doi: 10.1055/s-2007-1010647. No abstract available.
PubMed 1860446Sauerbruch T, Holl J, Sackmann M, Paumgartner G. Extracorporeal lithotripsy of pancreatic stones in patients with chronic pancreatitis and pain: a prospective follow up study. Gut. 1992 Jul;33(7):969-72. doi: 10.1136/gut.33.7.969.
PubMed 1644340Delhaye M, Arvanitakis M, Verset G, Cremer M, Deviere J. Long-term clinical outcome after endoscopic pancreatic ductal drainage for patients with painful chronic pancreatitis. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1096-106. doi: 10.1016/s1542-3565(04)00544-0.
PubMed 15625655Maydeo A, Bhandari S, Bapat M. Endoscopic balloon sphincteroplasty for extraction of large radiolucent pancreatic duct stones (with videos). Gastrointest Endosc. 2009 Oct;70(4):798-802. doi: 10.1016/j.gie.2009.05.004.
PubMed 19788986
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Large Pancreatic Radiolucent Stone
- ClinicalTrials.gov ID
- NCT04628273
- Acronym / sponsor ID
- Large PRS
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Nov 2020 (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.
Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.
Detailed description
- Treatment strategy of CP patients with large pancreatic stone：
- . For patients with large radiolucent stone，ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent.
- . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended.
- A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time.
- The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiolucent stone group | – | Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy |
| radiopaque stone group | – | Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CP patients with pancreatic radiolucent stones large than 5mm from March 2011 to December 2018 admitted to Changhai Hospital were included in this study. Patients with pancreatic radiopaque stones large than 5mm were matched as the control group, with a ratio of 1:2 according to admission time. CP was diagnosed primarily based on the Asia-Pacific consensus. Pancreatic radiopaque stone was diagnosed by CT scan while radiolucent stone by MRI or MRCP.
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm
Key exclusion criteria (1 listed)
- Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of 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 |
|---|---|---|
| encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy | Procedure or surgery | radiolucent stone group, radiopaque stone group |
Primary outcome
rate of pain relief
Time frame: after treatment to 2020-01-30
Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score > 10 after a decrease of > 50%)
2 secondary outcomes
rate of stone clearance
Time frame: during ERCP procedure
score of life quality
Time frame: after treatment to 2020-01-30
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 2 Dec 2020.
- Background: PubMed 20717860Tandan M, Reddy DN, Santosh D, Vinod K, Ramchandani M, Rajesh G, Rama K, Lakhtakia S, Banerjee R, Pratap N, Venkat Rao G. Extracorporeal shock wave lithotripsy and endotherapy for pancreatic calculi-a large single center experience. Indian J Gastroenterol. 2010 Jul;29(4):143-8. doi: 10.1007/s12664-010-0035-y. Epub 2010 Aug 18.
- Background: PubMed 1860446Neuhaus H. Fragmentation of pancreatic stones by extracorporeal shock wave lithotripsy. Endoscopy. 1991 May;23(3):161-5. doi: 10.1055/s-2007-1010647. No abstract available.
- Background: PubMed 1644340Sauerbruch T, Holl J, Sackmann M, Paumgartner G. Extracorporeal lithotripsy of pancreatic stones in patients with chronic pancreatitis and pain: a prospective follow up study. Gut. 1992 Jul;33(7):969-72. doi: 10.1136/gut.33.7.969.
- Background: PubMed 15625655Delhaye M, Arvanitakis M, Verset G, Cremer M, Deviere J. Long-term clinical outcome after endoscopic pancreatic ductal drainage for patients with painful chronic pancreatitis. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1096-106. doi: 10.1016/s1542-3565(04)00544-0.
- Background: PubMed 19788986Maydeo A, Bhandari S, Bapat M. Endoscopic balloon sphincteroplasty for extraction of large radiolucent pancreatic duct stones (with videos). Gastrointest Endosc. 2009 Oct;70(4):798-802. doi: 10.1016/j.gie.2009.05.004.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Changhai Hospital.
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 1 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
rate of pain relief (time frame: after treatment to 2020-01-30). 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 NCT04628273, which also lists 5 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 2 Dec 2020.