Phase II study: Radiofrequency ablation of locally advanced pancreatic cancer

Phase 2

Completed

Conditions: cancer of the pancreas
Pancreatic cancer
10015674

Registration Number: NL-OMON37585

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
3. Fully informed written consent given

Exclusion Criteria

1. Patients younger than 18 years
2. Pregnancy
3. Patients with distant metastases
4. Portal vein thrombosis seen on CT preoperatively

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter of the phase II study is safety.<br /><br><br /><br>The safety will be specified as the percentage of patients with complications<br /><br>directly related to RFA and requiring re-intervention (i.e. endoscopy,<br /><br>radiology, or surgery). This is also known as a complication of grade III or<br /><br>higher in the Clavien-Dindo classification (internationally accepted<br /><br>classification for surgical complications, see table 3) [20]. The complications<br /><br>directly related to RFA include pancreatitis, pancreatic fistula, perforation<br /><br>of the duodenum and thermal damage of the porto-mesenterial vein. Moreover all<br /><br>in-hospital complications or complications developed within 30 days after the<br /><br>RFA procedure will be evaluated according to the Clavien-Dindo classification.<br /><br><br /><br>The study will have a follow-up period of 3 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters of the study are: VAS pain score, length hospital<br /><br>stay, survival, progression free survival and CA19-9 response.</p><br>