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

Colorectal Cancer Clinical Trial

— POACC-1  

Official title:

Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700411
• Other study ID #: POACC-1
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2019
• Est. completion date: December 6, 2023

Study information

• Verified date: September 2023
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 6, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplastic Cells, Circulating

Intervention

Drug:
• Morphine
Morphine intravenous
• Piritramid
Piritramid intravenous
• Epidural
Perioperative epidural analgesia

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava
Czechia	General University Hospital	Prague
Czechia	T. Bata Regional Hospital Zlin	Zlin	Jihomoravsky Kraj

Sponsors (5)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	General University Hospital, Prague, Hospital Novy Jicin, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of circulating tumor cells prior to surgery to 2 - 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.	1 - 3 days before surgery to 4 weeks after surgery
Secondary	Pain assessment	Pain intensity assessed using Numerical Rating Scale (0-10)	3 days postoperatively