Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy

Pancreas Disease Clinical Trial

Official title:

Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy- A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514198
• Other study ID #: POP001
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2024
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

All patients (>18 yrs) undergoing elective Whipple's PD in Asian institute of gastroenterology, Hyderabad, Telangana.

Exclusion Criteria:

• On table inoperable patients

• Patients in cholangitis or bilirubin > 15 mg/dl

• Patients not giving consent for participation

• Patients with acute inflammatory states (cholangitis, sepsis, trauma, acute on chronic pancreatitis)

Related Conditions & MeSH terms

• Fistula
• Pancreas Disease
• Pancreatic Diseases
• Pancreatic Fistula
• Pancreatitis

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology/AIG Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate incidence of Post operative Pancreatitis and post operative pancreatic fistula among patients undergoing pancreaticoduodenectomies.	After pancreaticoduodenectomy surgery, pancreatitis occurs it is a local inflammatory process occurring in the area of the pancreatic anastomosis after pancreas resection could induce increased systemic amylase concentration, Amylase normal range is 28--100, if it exceeds the upper normal limits it leads to post operative pancreatitis, pancreatic fistula is defined as persistent drainage of amylase rich fluid (3x > than upper limit of normal serum amylase) for greater than 3 days.	10 days