Condition: Pancreatic Cancer · Surgery · Sponsor: Zealand University Hospital
The IMPULS trial is a randomized, triple-blinded, placebo controlled, single center, pilot trial examining the efficacy and safety of preoperative propranolol in patients scheduled for pancreatic cancer surgery. The study is conducted as a type 1 hybrid efficacy-implementation trial of 30 patients. This study is designed to provide pilot data for a future larger perioperative study of propranolol with the aim of improving outcomes for pancreatic cancer surgery. In total, 30 participants will be allocated in a 1:1 ratio with 15 participants enrolled in each trial arm (propranolol vs. placebo). Participants will be allocated to either 40 mg propranolol twice daily or placebo twice daily in 10 days prior to planned surgery. Primary outcomes: Evaluating the efficacy of preoperative propranolol on anxiety and in pro-tumorigenic changes (e.g., in the tumor tissue and in blood samples) in patients undergoing surgery for pancreatic cancer. Furthermore, to obtain follow up data (e.g., 90-day mortality, postoperative complications etc. on the patients receiving propranolol versus placebo). Heart rate variability among the participants will also be examined. Secondary: Examining the safety and tolerability of 40 mg preoperative propranolol twice daily in patients undergoing surgery for pancreatic cancer. Tertiary: Evaluating the feasibility and implementation of the trial (using the APEASE framework). This will help identify barriers and enablers to a future larger study. Short-ti…
This description comes directly from the study's public registry record.
Ismail Gögenur, Professor · +4547323181 · igo@regionsjaelland.dk
Adile Orhan, MD · +4560807762 · aor@regionsjaelland.dk
Always discuss trial participation with your own doctor first.
| Department of Surgical Gastroenterology | Copenhagen, Denmark | Recruiting |
| Ismail Gögenur | Køge, Denmark | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06145074