Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery

Phase 4

Completed

• Conditions: Circulating Tumor Cell; Colorectal Cancer
• Interventions: Drug: Epidural; Drug: Piritramid; Drug: Morphine

• Registration Number: NCT03700411
• Lead Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic

Brief Summary

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-07
• Study First Posted: 2018-10-09
• Study Start: 2019-01-07
• Status Verified: 2023-09
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-06
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• patients undergoing open radical surgery for colorectal cancer
• age over 18 years
• signed informed consent

Exclusion Criteria

• intolerance of the study drugs
• history of CRC surgery
• neoadjuvant therapy
• contraindications to epidural analgesia
• other malignancy not in permanent remission
• chronic opioid medication or opioid administration within 7 days preoperatively
• immunosuppressive or corticosteroid therapy
• surgery within 30 days preoperatively (except minor)
• chronic or acute infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural	Epidural	Perioperative epidural analgesia containing an opioid
Piritramid	Piritramid	Piritramid-based perioperative analgesia
Morphine	Morphine	Morphine-based perioperative analgesia

Primary Outcome Measures

Name	Time	Method
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery	1 - 3 days before surgery to 4 weeks after surgery	Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.

Secondary Outcome Measures

Name	Time	Method
Pain assessment	3 days postoperatively	Pain intensity assessed using Numerical Rating Scale (0-10)

Trial Locations

Locations (3)

T. Bata Regional Hospital Zlin; 🇨🇿 Zlin, Jihomoravsky Kraj, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia

General University Hospital; 🇨🇿 Prague, Czechia