NCT04606992

Brief Summary

This is a pilot feasibility study on high risk patients due to frailty and comorbidity who have early stage colon cancer (UICC 1). We will use a novel resection technique with expected less risk of complications called the Combined Endoscopic and Laparoscopic Surgery (CELS). After the histopathologic evaluation. Patients will be placed in either low risk or high risk group. Depending on this, they will be followed for 3 years or referred to standard resection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

August 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

October 8, 2020

Last Update Submit

August 15, 2022

Conditions

Colon Cancer Stage I

Outcome Measures

Primary Outcomes (1)

  • Resection margin

    R0, R1, R2

    1 month

Secondary Outcomes (1)

  • Complication rate

    1 month

Study Arms (1)

CELS resection

EXPERIMENTAL

All patients included in the study will be in this arm

Procedure: CELS

Interventions

CELSPROCEDURE

CELS resection for early colon cancer is a compromised resection performed in frail patients

CELS resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UICC stage 1 colon cancer
  • ASA score min. 3 and/or WHO PS score min. 1
  • CELS eligible resection
  • Biopsy show adenocarcinoma or suspicious lesion
  • No preop chemo or radiotherapy

You may not qualify if:

  • Hereditary cancer
  • Rectal cancer
  • Radiation downstaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Herlev University Hospital

Herlev, Denmark

Location

Hvidovre University Hospital

Hvidovre, Denmark

Location

Zealand University Hospital

Køge, Denmark

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ismail Gögenur, MD, DMsc

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 28, 2020

Study Start

February 10, 2020

Primary Completion

August 8, 2022

Study Completion

August 8, 2022

Last Updated

August 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(4)