Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Pancreas Cancer Clinical Trial

Official title:

Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566056
• Other study ID #: RH-2016-304-potawhipple
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: July 18, 2018

Study information

• Verified date: September 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.

Nevertheless, no studies have in detail described the acute (<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..

The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• the patient has undergone the Whipple procedure

• The patient is over 18 years ol

• The patient has signed a consent statement from the postoperative therapy ward

Exclusion Criteria:

• The patient did not receive 125 mg of methylprednisolone prior to the operation

• The patient did only undergo pancreatectomy

• The patient wasn't given epidural anesthesia

• the patient was given anesthesia through a mask

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Complications to Whipples procedure
Patients undergoing the Whipple procedure often tend to have a lot of complications. This study aims to investigate what complications these patients experience

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Eske Kvanner Aasvang

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)	Number of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure >65 mmHg, the first morning after surgery	6 am on the day after surgery