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Completed

NCT Number: NCT03813368

Whipples Resection in Octogenarians

Whipples resection is an operation that has a burden of high morbidity and mortality. It is performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when curative surgery has been performed. Short and long term outcomes however, have improved recently and the indications for curative resection have been increasingly extended, including operating on those that previously may have been considered too old to benefit from curative resection.

Little is known about the benefit of performing this procedure in the oldest patients. Performing Whipples resection in patients over the age of 70 has been reported and has been shown to result in satisfactory perioperative results with comparable long term outcomes to those under 70. However the benefit of performing the same procedure in the over 80 age group is less well reported and consistently presents a challenging decision for the clinician.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Lothian

Edinburgh, United Kingdom

About this study

Whipples resection is an operation that has a burden of high morbidity and mortality. It is performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when curative surgery has been performed. Short and long term outcomes however, have improved recently and the indications for curative resection have been increasingly extended, including operating on those that previously may have been considered too old to benefit from curative resection.

Little is known about the benefit of performing this procedure in the oldest patients. Performing Whipples resection in patients over the age of 70 has been reported and has been shown to result in satisfactory perioperative results with comparable long term outcomes to those under 70. However the benefit of performing the same procedure in the over 80 age group is less well reported and consistently presents a challenging decision for the clinician.

This study therefore aims to assess the short and long term outcomes of patients undergoing Whipples PD in the over 80 age group in Lothian. This will be combined with data from all the other units in Scotland that perform Whipples resection (Dundee, Glasgow and Aberdeen)

The primary outcome will be overall and disease free survival.

Participants will be identified by using procedure specific codes to identify those patients who underwent Whipples pancreaticoduodenectomy from the ORSOS prospectively collated theatre record database. The other centres in Scotland will identify their subjects via their own methodology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing Whipples PD from 1998-2018 in Scotland

Exclusion criteria

  • incorrectly coded as Whipples resection
  • Underwent non curative bypass procedures.

Treatment and study plan

Whipples pancreatico-duodenectomy

Procedure

Classic whipples and pylorus preserving

Primary outcomes

  1. survival

    Time frame: 10 years

    Time from surgery to death

  2. Disease free survival

    Time frame: 10 years

    Time from surgery to recurrence

Secondary outcomes

  1. Morbidity

    Time frame: 90 days

    Clavien Dindo grade of post-oepraitve complication

  2. Discharge Destination

    Time frame: 5 years

    Where the patient has been discharged from hospital to - home, nursing home, care home, home with support

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

Short and Long Term Outcomes of Whipples Resection in the Over 80s

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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