Whipples Resection in Octogenarians

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT03813368
• Lead Sponsor: University of Edinburgh

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Study Start: 2019-02-20
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival	10 years	Time from surgery to recurrence
survival	10 years	Time from surgery to death

Secondary Outcome Measures

Name	Time	Method
Morbidity	90 days	Clavien Dindo grade of post-oepraitve complication
Discharge Destination	5 years	Where the patient has been discharged from hospital to - home, nursing home, care home, home with support

Trial Locations

Locations (1)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom