Pancreatitis, ChronicEACHNCT05261997
Endotherapy for Painless Chronic Pancreatitis
A study testing extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct and pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets) in people with Pancreatitis, Chronic and Exocrine Pancreatic Insufficiency, run by Changhai Hospital at 1 site in China.
Trial summary
This is a prospective randomized controlled trial. . Patients will be divided into conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate pancreatic exocrine function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain
- What is being tested?
- extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct and pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Nov 2023
- 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
- diagnosed with chronic pancreatitis without pain attack related with chronic pancreatitis;
- calcified stone 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);
- with end-stage disease;
- pregnancy or lactation;
- refuse to write informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Zhuan Liao, professor, 86-021-31161004, liaozhuan@smmu.edu.cn
Lianghao Hu
About this study
Official title: Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients
This is a prospective randomized controlled trial. . Patients will be divided into conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.
Read the detailed description
This is a prospective, randomized controlled trial. Patients will be divided into conservative or endoscopic group and FE-1 is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.
Chronic pancreatitis (CP) is a pathologic fibro-inflammatory syndrome of the pancreas that eventually leads to damage of the gland in individuals with genetic, environmental and/or other risk factors. If widespread, this damage causes failure of exocrine and endocrine pancreatic function resulting in steatorrhea and diabetes. The global pooled incidence of CP is 10 cases [95% Confidence interval (CI) 8-12] per 100,000 general population per year. Endoscopic retrograde cholangiopancreatography (ERCP) and extracorporeal shock wave lithotripsy (ESWL) has become first-line therapy for patients with chronic pancreatitis according to guidelines. Endoscopic therapy has been proved effective and safe. The clearance rate of pancreatic stones was 42-76%, and the pain relief rate was 15-85%.
Pain is the major clinical features of CP and remained a major clinical challenge. It is present in up to 90% of patients and is the main cause of hospitalization in most patients.Patten of pain for patients with chronic pancreatitis differs widely.
However, some CP patients have never had abdominal pain during the course of the disease, and participants are often diagnosed with CP due to diabetes or steatorrhea, which are called painless CP, accounting for about 10% of the CP population. These patients are mainly characterized as pancreatic endocrine and exocrine insufficiency. Some studies proposed that painless CP may be related to the severity of inflammation and the pain sensitivity of patients, but the mechanism has not yet been elucidated.
It is still controversial whether painless CP requires active endoscopic intervention or not. The United European Gastroenterology evidence-based guidelines does not recommend endoscopic treatment in painless CP patients, but the recommendation is not supported by strong clinical research evidence. European Society of Gastrointestinal Endoscopy (ESGE) Guideline proposed whether active endoscopic treatment had a protective effect on the pancreatic function of patients with painless CP is still unconfirmed. On the contrary, a small sample study consisting of 41 CP patients by Katsushi found that endoscopic treatment can delay the progression of exocrine dysfunction in CP patients.Considering these contradicting results, it is urgent to conduct a clinical study to determine the effect of endoscopic treatment on preservation of pancreatic function in patients with CP.
Therefore, this study intends to use clinical prospective trials to explore whether patients with painless CP can benefit from active endoscopic minimally invasive interventions (including ERCP, ESWL, etc.), including slowing down the deterioration of pancreatic endocrine and exocrine function and improving patients' life quality and other aspects, and then provide an important reference basis for the clinical treatment of this type of patients.
Considering all these backgrounds, the primary outcome aimed to explore whether painless CP patients can benefit from endoscopic interventions (including ERCP, ESWL, etc.), including slowing down the deterioration of pancreatic endocrine and exocrine function, improving patients' life quality and other aspects. Based on the above, this study intends to provide important reference for the clinical treatment of painless CP patients.
- Conditions
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain, Cholangiopancreatography, Endoscopic Retrograde
- Being tested
- extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct, pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)
- Keywords
- chronic pancreatitis, endoscopic retrograde cholangiopancreatography, Exocrine Pancreatic Insufficiency, painless
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic ductProcedure or surgery
Also called ESWL, ERCP
In addition to drug administrated in the control group, patients in this group would be treated with ESWL and endoscopic drainage of the main pancreatic duct.
pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)Drug
Patients will receive drugs to control pancreatic insufficiency
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic group | Experimental | The patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 48h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was 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 for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary. Conservative treatments similar to patients in the control group were given in endoscopic group according to patients' condition. Receives: Procedure: extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct |
| Conservative group | Other | Patients will have pancreatic enzymes (Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table) to control symptoms of exocrine pancreatic insufficiency. The recommended initial dose for adults is (25 000-40 000) IU lipase per meal (40 000 IU for meals and 20 000 IU for snacks), which can be increased until the PEI is relieved. The maximum recommended dose is (75 000-80 000) IU lipase per meal. Actions including drugs(Acarbose Tablets, Glucophage, Glimepirde Tablets) or insulin(Biosynthetic Human Insulin Injection, Tresiba or both) would also be taken for control of diabetes according to patients' glucose levels. Receives: Drug: pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
exocrine function of the pancreas assessed by the value of fecal elastase in μg/g
Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, including normal exocrine function, newly developed PEI, PEI relief, PEI persisting.
Measured: 12 months
Secondary outcomes (4)
endocrine function of the pancreas assessed by glycosylated hemoglobin in %.
It is considered as pancreatic endocrine function insufficiency when glycosylated hemoglobin >6.5%， the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
Measured: 12 months
endocrine function of the pancreas assessed by fasting blood glucose in mmol/L
It is considered as pancreatic endocrine function insufficiency when fasting blood glucose >6.1mmol/L, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
Measured: 12 months
endocrine function of the pancreas assessed by fasting C peptide in ug/L
It is considered as pancreatic endocrine function insufficiency when fasting C peptide<1.1ug/L, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
Measured: 12 months
life quality assessed by SF-36 questionnaire
life quality assessed by the MOS item short from health survey (SF-36) questionnaire
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 posted2 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Patients will be divided into conservative treatment group or endoscopic treatment group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, MD, Principal investigator, Shanghai Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261997
- Sponsor's protocol ID
- Painless CP
- Acronym
- EACH
- Status last verified
- Feb 2022
- First submitted
- 24 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients
- ClinicalTrials.gov ID
- NCT05261997
- Acronym / sponsor ID
- EACH / Painless CP
- Conditions
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain, Cholangiopancreatography, Endoscopic Retrograde
- Keywords
- chronic pancreatitis, endoscopic retrograde cholangiopancreatography, Exocrine Pancreatic Insufficiency, painless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 2 Mar 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 is a prospective randomized controlled trial. . Patients will be divided into conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.
Detailed description
This is a prospective, randomized controlled trial. Patients will be divided into conservative or endoscopic group and FE-1 is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.
Chronic pancreatitis (CP) is a pathologic fibro-inflammatory syndrome of the pancreas that eventually leads to damage of the gland in individuals with genetic, environmental and/or other risk factors. If widespread, this damage causes failure of exocrine and endocrine pancreatic function resulting in steatorrhea and diabetes. The global pooled incidence of CP is 10 cases [95% Confidence interval (CI) 8-12] per 100,000 general population per year. Endoscopic retrograde cholangiopancreatography (ERCP) and extracorporeal shock wave lithotripsy (ESWL) has become first-line therapy for patients with chronic pancreatitis according to guidelines. Endoscopic therapy has been proved effective and safe. The clearance rate of pancreatic stones was 42-76%, and the pain relief rate was 15-85%.
Pain is the major clinical features of CP and remained a major clinical challenge. It is present in up to 90% of patients and is the main cause of hospitalization in most patients.Patten of pain for patients with chronic pancreatitis differs widely.
However, some CP patients have never had abdominal pain during the course of the disease, and participants are often diagnosed with CP due to diabetes or steatorrhea, which are called painless CP, accounting for about 10% of the CP population. These patients are mainly characterized as pancreatic endocrine and exocrine insufficiency. Some studies proposed that painless CP may be related to the severity of inflammation and the pain sensitivity of patients, but the mechanism has not yet been elucidated.
It is still controversial whether painless CP requires active endoscopic intervention or not. The United European Gastroenterology evidence-based guidelines does not recommend endoscopic treatment in painless CP patients, but the recommendation is not supported by strong clinical research evidence. European Society of Gastrointestinal Endoscopy (ESGE) Guideline proposed whether active endoscopic treatment had a protective effect on the pancreatic function of patients with painless CP is still unconfirmed. On the contrary, a small sample study consisting of 41 CP patients by Katsushi found that endoscopic treatment can delay the progression of exocrine dysfunction in CP patients.Considering these contradicting results, it is urgent to conduct a clinical study to determine the effect of endoscopic treatment on preservation of pancreatic function in patients with CP.
Therefore, this study intends to use clinical prospective trials to explore whether patients with painless CP can benefit from active endoscopic minimally invasive interventions (including ERCP, ESWL, etc.), including slowing down the deterioration of pancreatic endocrine and exocrine function and improving patients' life quality and other aspects, and then provide an important reference basis for the clinical treatment of this type of patients.
Considering all these backgrounds, the primary outcome aimed to explore whether painless CP patients can benefit from endoscopic interventions (including ERCP, ESWL, etc.), including slowing down the deterioration of pancreatic endocrine and exocrine function, improving patients' life quality and other aspects. Based on the above, this study intends to provide important reference for the clinical treatment of painless CP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be divided into conservative treatment group or endoscopic treatment group.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic group | Experimental | Procedure: extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic ductThe patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 48h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was 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 for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary. Conservative treatments similar to patients in the control group were given in endoscopic group according to patients' condition. |
| Conservative group | Other | Drug: pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)Patients will have pancreatic enzymes (Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table) to control symptoms of exocrine pancreatic insufficiency. The recommended initial dose for adults is (25 000-40 000) IU lipase per meal (40 000 IU for meals and 20 000 IU for snacks), which can be increased until the PEI is relieved. The maximum recommended dose is (75 000-80 000) IU lipase per meal. Actions including drugs(Acarbose Tablets, Glucophage, Glimepirde Tablets) or insulin(Biosynthetic Human Insulin Injection, Tresiba or both) would also be taken for control of diabetes according to patients' glucose levels. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with chronic pancreatitis without pain attack related with chronic pancreatitis;
- calcified stone 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 (5 listed)
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- with end-stage disease;
- pregnancy or lactation;
- refuse to write informed consent
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 lithotripsy and endoscopic drainage of the main pancreatic ductAlso: ESWL, ERCPIn addition to drug administrated in the control group, patients in this group would be treated with ESWL and endoscopic drainage of the main pancreatic duct. | Procedure or surgery | Endoscopic group |
| pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)Patients will receive drugs to control pancreatic insufficiency | Drug | Conservative group |
Primary outcome
exocrine function of the pancreas assessed by the value of fecal elastase in μg/g
Time frame: 12 months
Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, including normal exocrine function, newly developed PEI, PEI relief, PEI persisting.
4 secondary outcomes
endocrine function of the pancreas assessed by glycosylated hemoglobin in %.
Time frame: 12 months
endocrine function of the pancreas assessed by fasting blood glucose in mmol/L
Time frame: 12 months
endocrine function of the pancreas assessed by fasting C peptide in ug/L
Time frame: 12 months
life quality assessed by SF-36 questionnaire
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 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Pancreatitis, Chronic
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
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.
Zhuan Liao, MD principal investigator
Shanghai Changhai Hospital, Shanghai, China
1 site 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 and endoscopic drainage of the main pancreatic duct and pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets) in people with Pancreatitis, Chronic and Exocrine Pancreatic Insufficiency, 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 5 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 2 Mar 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 Zhuan Liao (13061921980, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exocrine function of the pancreas assessed by the value of fecal elastase in μg/g (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 2 Mar 2022.