Endotherapy for Painless Chronic Pancreatitis

Abdominal Pain Clinical Trial

— EACH  

Official title:

Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261997
• Other study ID #: Painless CP
• Status: Recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: November 2023

Study information

• Verified date: February 2022
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 13061921980
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Cholangiopancreatography, Endoscopic Retrograde
• Exocrine Pancreatic Insufficiency
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct
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.

Drug:
• 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

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI in kg/m^2	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.	12 months
Other	Treatment-related costs in RMB from initial enrollment to the end of the study	The total costs in RMB of each hospitalization	12 months
Primary	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	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	life quality assessed by SF-36 questionnaire	life quality assessed by the MOS item short from health survey (SF-36) questionnaire	12 months