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Endotherapy for Painless Chronic Pancreatitis (EACH)

Primary Purpose

Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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)
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Chronic focused on measuring chronic pancreatitis, endoscopic retrograde cholangiopancreatography, Exocrine Pancreatic Insufficiency, painless

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Endoscopic group

Conservative group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
life quality assessed by SF-36 questionnaire
life quality assessed by the MOS item short from health survey (SF-36) questionnaire

Full Information

First Posted
November 24, 2021
Last Updated
February 26, 2022
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05261997
Brief Title
Endotherapy for Painless Chronic Pancreatitis
Acronym
EACH
Official Title
Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Abdominal Pain, Cholangiopancreatography, Endoscopic Retrograde
Keywords
chronic pancreatitis, endoscopic retrograde cholangiopancreatography, Exocrine Pancreatic Insufficiency, painless

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be divided into conservative treatment group or endoscopic treatment group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conservative group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct
Other Intervention Name(s)
ESWL, ERCP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)
Intervention Description
Patients will receive drugs to control pancreatic insufficiency
Primary Outcome Measure Information:
Title
exocrine function of the pancreas assessed by the value of fecal elastase in μg/g
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
endocrine function of the pancreas assessed by glycosylated hemoglobin in %.
Description
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.
Time Frame
12 months
Title
endocrine function of the pancreas assessed by fasting blood glucose in mmol/L
Description
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.
Time Frame
12 months
Title
endocrine function of the pancreas assessed by fasting C peptide in ug/L
Description
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.
Time Frame
12 months
Title
life quality assessed by SF-36 questionnaire
Description
life quality assessed by the MOS item short from health survey (SF-36) questionnaire
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
BMI in kg/m^2
Description
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Time Frame
12 months
Title
Treatment-related costs in RMB from initial enrollment to the end of the study
Description
The total costs in RMB of each hospitalization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Liao
Phone
13061921980
Email
liaozhuan@smmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yangyang Qian
Phone
13818040017
Email
drfionachien@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, MD
Organizational Affiliation
Shanghai Changhai Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, professor
Phone
86-021-31161004
Email
liaozhuan@smmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Lianghao Hu
First Name & Middle Initial & Last Name & Degree
Yangyang Qian

12. IPD Sharing Statement

Plan to Share IPD
No

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Endotherapy for Painless Chronic Pancreatitis

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