Surgical Apgar Score After Whipple Procedure in Pancreatic Cancer Patients

NCT03470948 | Terminated DMC

• 1 other identifier: TataMH
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

surgical apgar score, postoperative complication

Outcome Measures

Primary Outcomes (1)

• Incidence of major postoperative complications and/or death within 30 days of surgery

  Mortality

  30 days postoperative

Interventions

Observe postoperative complications OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study to be done for a period of 60 months. Upto 750 patients in 60 months, thus 150 patients in 12 months

You may qualify if:

• patients undergoing Whipple's procedure for pancreatic cancer,
• between age group of 18-75years,
• with ASA-PS I - III.

You may not qualify if:

• Age \<18 and \>75yrs.
• Pt not consenting,
• ASA IV \& above

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vijaya Patil, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: March 27, 2018
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)