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

NCT04514198 | Completed DMC

• 1 other identifier: POP001
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

AIM To determine association between postoperative pancreatitis and pancreatic fistula OBJECTIVES

1. 1.To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy
2. 2.To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula
3. 3.To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula
4. 4.to identify the possible predictors of post operative pancreatitis.
5. 5.to investigate the association between post operative pancreatitis and post operative pancreatic fistula.

Conditions

Pancreas Disease

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sample size : Required 35 subjects

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Shasheendra Y, Ahmed Z, Shetty MG, Hazarathaiah N, Rebala P, Rao GV. Association of Postoperative Hyperamylasemia With Clinically Relevant Postoperative Pancreatic Fistula in Pancreatoduodenectomy. Cureus. 2024 Jan 30;16(1):e53257. doi: 10.7759/cureus.53257. eCollection 2024 Jan.

  PMID: 38435944 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Dr Pradeep Rebala, MBBS MS MCH

  Asian Institute of Gastroenterology, India

  STUDY CHAIR

• Dr Shasheendra yanagandula, MBBS MS

  Asian Institute of Gastroenterology, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: March 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

IN (1)