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NCT03470948
Surgical Apgar Score After Whipple Procedure in Pancreatic Cancer Patients
trial testing Observe postoperative complications in Postoperative Complications in 263 participants. Terminated before completion.
26 March 2021
Quick facts
| Lead sponsor | Tata Memorial Hospital |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 263 |
| Start date | 27 March 2018 |
| Primary completion | 26 March 2021 |
| Estimated completion | 26 March 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Observe postoperative complications
Conditions studied
- Postoperative Complications — all drugs for Postoperative Complications →
Sponsor
Tata Memorial Hospital
Who can join
Adults 18 to 75, any sex, with Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03470948 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tata Memorial Hospital
- Last refreshed: 1 April 2021
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