Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03470948 |
| Other study ID # |
TataMH |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 27, 2018 |
| Est. completion date |
March 26, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Tata Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
This is a prospective, observational, non-interventional, non-randomized study involving the
adult patients undergoing Whipple's procedure. Institutional ethics permission and written
informed consent will be taken from the patient. The study duration will be for a period of 5
years, but the data of the first one year will be analysed and will presented as a thesis for
MD (Anaesthesia). Administration of anaesthesia and reversal of neuromuscular blocking drugs
will be carried as per the institutional routine practice and at the discretion of
anaesthesiologist in charge. The study will include patients undergoing Whipple's procedure
for pancreatic cancer, between age group of 18-75years, with ASA-PS I - III. Preoperative,
intraoperative and outcome variables as defined according to the definitions established by
the American college of surgeons National Surgeons Quality Improvement Program (NSQIP) will
be recorded. A total of 11 preoperative, 14 intraoperative and 21 outcome variables will be
collected (see Appendix). All the post operative outcome variables will be defined.
Preoperative comorbid conditions will also be recorded. SAS will be calculated from three
intraoperative variables (1) the estimated blood loss (EBL), (2) lowest heart rate (HR), and
(3) lowest mean arterial pressure (MAP). For analysis, SAS will be classified as low (≤ 4
points), intermediate (5-6 points) and high (7-9 points). Complications including mortality
will be assessed Upto 30 days postoperatively. The categorization of the complications as
major and minor is consistent with NSQIP definition. Major complications include acute kidney
injury, blood loss ≥ 2000ml, transfusion requiring ≥ 4 U packed blood cells within 72 hours
of surgery, cardiac or respiratory arrest requiring cardiopulmonary resuscitation (CPR), coma
for 24 hours or longer, deep venous thrombosis, septic shock, acute myocardial infarction,
new onset arrhythmias, unplanned re-intubation, ventilator use for 48 hours or longer,
pneumonia, pulmonary embolism, stroke, wound disruption, deep or organ space surgical site
infection, sepsis, systemic inflammatory response syndrome, unplanned intensive care unit
(ICU) admission, need for reoperation, anastomotic leak or fistula, vascular, ureteral or
neural injuries, unplanned readmission < 30 days of discharge, and death. The occurrence of
major postoperative complications within 30 days of surgery represents primary outcome. Some
of the patients do follow-up at day 30 to the OPD and those patients who don't follow-up at
day 30 will be assessed and interviewed by telephone. If they are not able to follow-up on
day 30, they will be contacted telephonically and interviewed for a period of 10-15 minutes,
by a research nurse or a research doctor. Only mortality will be noted at day 30.
