Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy
Condition: Pancreas Disease
MeSH terms: Pancreatitis; Pancreatic Fistula; Pancreatic Diseases; Fistula
Study type: Observational

Summary: 
      AIM

      To determine association between postoperative pancreatitis and pancreatic fistula

      OBJECTIVES

        1. To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after
           pancreaticoduodenectomy

        2. To determine role of serum amylase levels on day 1 to predict clinically relevant
           pancreatic fistula

        3. To determine risk factors for postoperative pancreatitis and postoperative pancreatic
           fistula

      Primaryendpoint:

      Incidence of post operative pancreatitis and post operative pancreatic fistula.

      Secondaryendpoints:

        1. to identify the possible predictors of post operative pancreatitis.

        2. to investigate the association between post operative pancreatitis and post operative
           pancreatic fistula.

      MATERIAL AND METHODS

      Study centre:

      Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology,
      Hyderabad

      Study population:

      Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective
      observational study

      Study period:

      Study will be conducted till desired sample size achieved or March 2020 to march 2022
    

Detailed description: 
      STUDY PROCEDURE:

      Demographic, pathological and intraoperative data will be recorded in a prospectively
      maintained database populated from a combination of electronic patient records, preoperative
      imaging and anaesthetic charts. Preoperative clinical data included age, gender, body mass
      index (BMI), and the results of serum biochemical investigations including serum bilirubin,
      urea and amylase. The serum amylase measured throughout the study period is total amylase.
      Preoperative computed tomography images will beanalyzed to calculate pancreatic duct diameter
      at the line of transection of the pancreas anterior to the portal vein. Intraoperative data
      included reconstruction technique, texture of the pancreatic remnant and estimated blood
      loss. Blood loss data will be compiled from a combination of anaesthetic charts and
      perioperative blood transfusion data. Specimens will be dichotomized according to whether
      their pathology was associated with hard pancreatic parenchyma [pancreatic ductal
      adenocarcinoma (PDAC) and chronic pancreatitis] or with soft or normal pancreatic parenchyma
      (ampullary carcinoma, duodenal carcinoma, cholangiocarcinoma, neuroendocrine tumours and
      other lesions). Outcome data included length of stay in a critical care environment [defined
      as either an intensive care unit (ICU) or a surgical high-dependency unit (SHDU)] and length
      of postoperative hospital stay. All postoperative complications will be prospectively
      recorded and graded according to the International Study Group on Pancreatic Fistula (ISGPF)
      and International Study Group of Pancreatic Surgery (ISGPS) classifications and the
      Clavien-Dindo classification. Complications of ISGPS Grades B and C and Clavien-Dindo Grades
      III-V are considered clinically significant. Mortality will be recorded at 30-day and 90-day
      time-points.

      Serum amylase will be systematically measured on POD1 and POD3 according to our institutional
      policy. No additional radiological or laboratory studies are required for the diagnosis of
      postoperative pancreatitis. No specific protocols for the treatment of POP will be followed
      during the study period because none are available. Due to the absence of a widely accepted
      definition, POP is defined according to Connor's definition1 as an elevation in serum
      pancreatic amylase above the upper limit of normal on postoperative day (POD) 0 or 1. At our
      institution, the upper limit of normal for serum pancreatic amylase is 100 U/L.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sample size : Required 35 subjects