---
title: Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery
nct_id: NCT03700411
overall_status: COMPLETED
phase: PHASE4
sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
study_type: INTERVENTIONAL
primary_condition: Colorectal Cancer
countries: Czechia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03700411.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03700411"
ct_last_update_post_date: 2023-12-07
last_seen_at: "2026-05-12T06:34:00.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery

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

**NCT ID:** [NCT03700411](https://clinicaltrials.gov/study/NCT03700411)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 125
- **Lead Sponsor:** The Institute of Molecular and Translational Medicine, Czech Republic
- **Collaborators:** General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Hospital Novy Jicin
- **Conditions:** Colorectal Cancer, Circulating Tumor Cell
- **Start Date:** 2019-01-07
- **Completion Date:** 2023-12-06
- **CT.gov Last Update:** 2023-12-07

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Morphine** (ACTIVE_COMPARATOR) — Morphine-based perioperative analgesia
- **Piritramid** (ACTIVE_COMPARATOR) — Piritramid-based perioperative analgesia
- **Epidural** (ACTIVE_COMPARATOR) — Perioperative epidural analgesia containing an opioid

## Interventions

- **Morphine** (DRUG) — Morphine intravenous
- **Piritramid** (DRUG) — Piritramid intravenous
- **Epidural** (DRUG) — Perioperative epidural analgesia

## Primary Outcomes

- **Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery** _(time frame: 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 Outcomes

- **Pain assessment** _(time frame: 3 days postoperatively)_

## Locations (3)

- T. Bata Regional Hospital Zlin, Zlin, South Moravian, Czechia
- University Hospital Ostrava, Ostrava, Czechia
- General University Hospital, Prague, Czechia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.t. bata regional hospital zlin|zlin|south moravian|czechia` — added _(2026-05-12)_
- `locations.university hospital ostrava|ostrava||czechia` — added _(2026-05-12)_
- `locations.general university hospital|prague||czechia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03700411.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03700411*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*