Endotherapy for Painless Chronic Pancreatitis
EACH
Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients
1 other identifier
interventional
60
1 country
1
Brief 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. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedMarch 2, 2022
February 1, 2022
1.7 years
November 24, 2021
February 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (4)
endocrine function of the pancreas assessed by glycosylated hemoglobin in %.
12 months
endocrine function of the pancreas assessed by fasting blood glucose in mmol/L
12 months
endocrine function of the pancreas assessed by fasting C peptide in ug/L
12 months
life quality assessed by SF-36 questionnaire
12 months
Other Outcomes (2)
BMI in kg/m^2
12 months
Treatment-related costs in RMB from initial enrollment to the end of the study
12 months
Study Arms (2)
Endoscopic group
EXPERIMENTALThe 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
OTHERPatients 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.
Interventions
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.
Patients will receive drugs to control pancreatic insufficiency
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhuan Liao, MD
Shanghai Changhai Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 24, 2021
First Posted
March 2, 2022
Study Start
March 1, 2022
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share