Clinical trial NCT05261997: Endotherapy for Painless Chronic Pancreatitis
Official title: Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Abdominal Pain
Cholangiopancreatography, Endoscopic Retrograde
Keywords: chronic pancreatitis
endoscopic retrograde cholangiopancreatography
Exocrine Pancreatic Insufficiency
painless
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into conservative treatment group or endoscopic treatment group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: exocrine function of the pancreas assessed by the value of fecal elastase in μg/g
timeFrame: 12 months
Secondary outcomes:
measure: endocrine function of the pancreas assessed by glycosylated hemoglobin in %.
timeFrame: 12 months
measure: endocrine function of the pancreas assessed by fasting blood glucose in mmol/L
timeFrame: 12 months
measure: endocrine function of the pancreas assessed by fasting C peptide in ug/L
timeFrame: 12 months
measure: life quality assessed by SF-36 questionnaire
timeFrame: 12 months
Other outcomes:
measure: BMI in kg/m^2
timeFrame: 12 months
measure: Treatment-related costs in RMB from initial enrollment to the end of the study
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Shanghai Changhai Hospital, Shanghai, China
name: Zhuan Liao, MD
role: PRINCIPAL_INVESTIGATOR
References: