Whipples Resection in Octogenarians

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813368
• Other study ID #: 258426
• Status: Completed
• Start date: February 20, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• incorrectly coded as Whipples resection

• Underwent non curative bypass procedures.

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Procedure:
• Whipples pancreatico-duodenectomy
Classic whipples and pylorus preserving

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	Time from surgery to death	10 years
Primary	Disease free survival	Time from surgery to recurrence	10 years
Secondary	Morbidity	Clavien Dindo grade of post-oepraitve complication	90 days
Secondary	Discharge Destination	Where the patient has been discharged from hospital to - home, nursing home, care home, home with support	5 years