NCT03813368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 10, 2018

Last Update Submit

June 12, 2024

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • survival

    Time from surgery to death

    10 years

  • Disease free survival

    Time from surgery to recurrence

    10 years

Secondary Outcomes (2)

  • Morbidity

    90 days

  • Discharge Destination

    5 years

Interventions

Whipples pancreatico-duodenectomyPROCEDURE

Classic whipples and pylorus preserving

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had whipples pancreatico-duodenectomy in Scotland

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Michael Hughes

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

January 23, 2019

Study Start

February 20, 2019

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

GB(1)