Whipples Resection in Octogenarians

NCT ID: NCT03813368

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2019-07-01

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Whipples pancreatico-duodenectomy

Classic whipples and pylorus preserving

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hughes

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

NHS Lothian

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

258426

Identifier Type: -

Identifier Source: org_study_id