Randomized, double-blind study on the efficacy of somatostatin bolus administration followed by a short intravenous infusion as prophylaxis for acute pancreatitis after endoscopic retrograde cholangiopancreatography

INTERVENTION: Trade Name: SOMATOSTATINA COMBINO PHARM 3 mg Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: SOMATOSTATINA CAS Number: 38916‐34‐6 Other descriptive name: SOMATOSTATIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.5‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: To evaluate the efficacy of somatostatin administration as prophylaxis for acute pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). ; MedDRA version: 9.1 Level: LLT Classification code 10033647 Term: Acute pancreatitis PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of intravenous bolus administration of somatostatin followed by a short continuous infusion (4 hours) as prophylaxis for acute pancreatitis in patients undergoing ERCP for biliary-pancreatic pathology in our setting. To study the incidence and severity of post-ERCP pancreatitis. Primary endpoint(s): 1) Parameters prior to the examination: age, sex, patient origin (Day Hospital or admitted to our hospital), indication of the examination. Previous patient history: acute pancreatitis prior to ERCP, chronic pancreatitis, previous history of acute pancreatitis post-ERCP, previous acute pancreatitis of another etiology, suspected sphincter of Oddi dysfunction, pancreas divisum, previous history of cholecystectomy, sphincterotomy prior to the examination, common bile duct diameter by ultrasound, previous administration of antibiotic, type of antibiotic used. 2) Parameters related to the therapeutic maneuvers performed: pancreatic sphincterotomy, biliary sphincterotomy, biliary dilation, pancreatic dilation, biliary prosthesis, pancreatic prosthesis, pre-cut, pancreatic acinarization, number of pancreatic injections (0, 1, >1), difficulty in cannulation (easy (1-5), moderate (6-15), difficult (>15)), ml contrast used, use of coagulation in the sphincterotomy, need for sclerosing injection, stone extraction, use of guides for biliary cannulation, use of guides in pancreatic cannulation, duration of ERCP, intramural contrast injection, performance of pancreatic cytology, cholangiography, pancreatography.; 3) Analytical parameters prior to the procedure: baseline levels of amylase, lipase, C-reactive protein, interleukin-6, interleukin-10, TNF-alpha, complete blood count and biochemistry panel with liver function tests, electrolytes, renal function tests, and blood glucose. Venous acid-base balance.; 4) Analytical parameters 4 hours after the ERCP: amylase, lipase, C-reactive protein, interleukin-6, interleukin-10, TNF-alpha, complete blood count and biochemistry panel with liver function tests, electrolytes, renal function tests, and blood glucose. Venous acid-base balance.; 5) Post-ERCP clinical course to detect possible complications: post-ERCP pancreatitis, hemorrhage, perforation, cholangitis. In the event of post-ERCP pancreatitis, assess the severity of the pancreatitis (Cotton Criteria): 1. mild (evidence of pancreatitis with an increase in amylase more than twice the upper limit of normal within 24 hours of the procedure, requiring hospitalization for 2–3 days); 2. moderate (hospitalization for 4–10 days); 3. severe (more than 10 days or any complication of pancreatitis: necrosis, pseudocyst, abscess, requiring percutaneous or surgical drainage). Define the severity of pancreatitis according to Ranson criteria in the first 48 hours: 1) first 24 hours: Age > 55 years, leukocytes > 16,000, glucose > 200 mg/dL, LDH > 350 U/L, AST > 250 U/L; 2) At 48 hours: decreased hematocrit, increased urea > 5 mg/dl, serum calcium < 8 mg/dl, pO2 < 60 mm Hg, base deficit > 4 mEq/L, positive balance > 6 L. Severity assessment according to radiological findings: grade A (normal pancreas morphology), grade B (diffuse or localized enlargement of the pancreas), grade C (pancreatic abnormalities with peripancreatic inflammatory changes), grade D (fluid accumulation in one location), grade E (accumulation in 2 or more locations in or near the pancreas).; 6) Complications related to pharmacological treatment: any undesirable effect observed during follow-up will be recorded, whether initially attributable to the treatment or not. The reporting of serious and unexpected adverse events will be carried out following the model and general instructions set out in Annex 8 of the Royal Decree of April 16, which establishes the requirements for conducting clinical trials with medicinal products. Since they may be related to the administration of somatostatin, the following complications will be specifically recorded: 1) dizziness, nausea or a sensation of facial heat, abdominal pain, and diarrhea (mostly due to overly rapid administration, which can be avoided by administering it slowly); 2) hypoglycemia followed 2–3 hours after the infusion by hyperglycemia. MAIN VARIABLES TO BE ANALYZED: 1. Incidence and severity of post-ERCP pancreatitis in the somatostatin group and the placebo group. 2. Safety of somatostatin in patients receiving pharmacological prophylaxis before and after ERCP. 3. Study of risk factors