Pancreatic Cancer
Conditions
Brief summary
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
Interventions
Sponsors
Lund University
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing pancreaticoduodenectomy of both sexes * Patients with predicted risk score of 10 or less of pancreatic fistula * Written informed consent * Expected survival time \> 6 months
Exclusion criteria
* Patients with predicted high risk of fistula with a risk score above 10 * Patients with intraabdominal abscess or infection * ASA score \> 3 * Pregnancy * Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall morbidity rate | 90 days post operatively | Post operative morbidity |
Secondary
| Measure | Time frame |
|---|---|
| Severe morbidity rate as classified by Clavien-Dindo >3 | 90 days post operatively |
| Fistula rate according to ISGPF | 90 days post operatively |
| Intraabdominal abscess rate | 90 days post operatively |
| Wound infection rate | 90 days post operatively |
| Delayed gastric emptying according to ISGPF | 90 days post operatively |
| Mortality rate (in-hospital, 30 and 90 days) | 90 days post operatively |
| Need of interventional radiology | 90 days post operatively |
| Need for reoperation | 90 days post operatively |
| Hospital stay | 90 days post operatively |
| Readmission rate | 90 days post operatively |
| Postpancreatectomy bleeding according to ISGPF | 90 days post operatively |
Countries
Sweden
Contacts
Primary ContactBergthor Björnsson
Outcome results
None listed