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Postoperative ComplicationsNCT03470948

Surgical Apgar Score After Whipple Procedure in Pancreatic Cancer Patients

An observational study of Postoperative Complications, run by Tata Memorial Hospital at 1 site in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postoperative Complications
What is being tested?
Observe postoperative complications
How many people
263 participants
Where
1 siteIndia
Study dates
27 Mar 2018to 26 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

Other trials in India

About this study

Official title: Utility of Surgical Apgar Score in Predicting Post-Operative Complications After Whipple Procedure in Pancreatic Cancer Patients

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.

Read the detailed 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.

Being tested
Observe postoperative complications
Keywords
surgical apgar score, postoperative complication
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observe postoperative complicationsOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Mortality

    Measured: 30 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start27 Mar 2018
  3. Primary completion26 Mar 2021
  4. Study completion26 Mar 2021

Why it stopped: No manpower to conduct the study further

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470948
Sponsor's protocol ID
TataMH
Status last verified
Mar 2021
First submitted
13 Mar 2018
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications, run by Tata Memorial Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: No manpower to conduct the study further). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of major postoperative complications and/or death within 30 days of surgery (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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