Surgical Apgar Score After Whipple Procedure in Pancreatic Cancer Patients

NCT03470948 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 263

Last updated 2021-04-01

No results posted yet for this study

Summary

The number of new cases of pancreatic cancer is 12.4 per 100,000 men and women per year. The number of deaths is 10.9 per 100,000 men and women per year. These rates are age-adjusted and based on 2009-2013 cases and deaths1. This cancer has a very poor prognosis and around 7.7% of these patients have a 5 years survival rate. Whipple procedure is the surgical treatment option for cancer pancreas, where the head of the pancreas, the gallbladder, part of the stomach, part of the small intestine, and the bile duct are removed.Those that undergoes this procedure, the 5 year survival rate increases to about 20%2. The duration of intensive care unit monitoring and hospital stay are longer than for most upper gastrointestinal surgeries. Pancreaticoduodenectomy is a major operation, carrying significant risk of morbidity and mortality with 30 - 60% complication rate3. The possibility of identifying patients at risk for postoperative complications and targeting them from surveillance and early treatment offers an opportunity to develop interventions that might significantly improve outcomes and efficiency. Gawande et al. developed and validated the surgical Apgar score (SAS) and demonstrated that SAS can be useful for rating the condition of patients after general or vascular surgery4. SAS is based on intraoperative blood loss, blood pressure, and heart rate3. The score is very simple and easy to calculate and can be available immediately after surgery. Several validation studies have reported that SAS is useful for predicting the risk of complications associated with various procedures4-10. We investigated this SAS could predict major postoperative complications among patients undergoing Whipples procedure in patients with pancreatic cancer.

Conditions

  • Postoperative Complications

Interventions

OTHER

Observe postoperative complications

The aim of this study is to confirm the utility of a 10-point Surgical Apgar Score to rate surgical outcomes in Whipples procedure in patients with pancreatic cancer.

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Vijaya Patil, MD · Tata Memorial Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2021-03-26
Completion
2021-03-26

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470948 on ClinicalTrials.gov