Randomized phase II trial with propranolol and etodolac for patients with tumor resection of the pancreatic head.

Phase 1

• Conditions: Patients with pancreatic carcinoma treated by pancreatoduodenectomy.; MedDRA version: 21.0Level: LLTClassification code 10033659Term: PancreatoduodenectomySystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-000415-25-DE
• Lead Sponsor: niversity Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

· Patients planned for elective pancreatoduodenectomy
· Patients eligible for perioperative therapy with propranolol / etodolac
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

· Prior / concurrent therapy with beta-blockers, Cox-2 inhibitors or
Etodolac
· Known allergies to beta-blockers, Cox-2 inhibitors or Etodolac
· Patients with a known long-term medication that may cause severe
interactions with propranolol / etodolac

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified