NCT01351714

Brief Summary

When performing a resection of the right colon due to cancer one aims not only to remove the tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph nodes are located along the arteries supplying the right colon. Through using a preoperative CT scan which can map these arteries very precisely one can ligate these vessels closer to their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This study aims to compare patients operated more radically through use of preoperative CT which maps the mentioned arteries with patients operated in the standard way.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

9.7 years

First QC Date

May 9, 2011

Last Update Submit

September 27, 2020

Conditions

Colon Cancer

Keywords

D3 resectionright colectomyMDCT angiographylymphadenectomysaferight colonpreoperative

Outcome Measures

Primary Outcomes (1)

  • Number of additional lymph nodes removed through radical D3 resection

    The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.

    1 year

Secondary Outcomes (1)

  • Disease free survival 2 and 5 years after initial surgery

    5 years

Study Arms (1)

D3 resection

OTHER

Radical D3 resection of the right colon through the use of preoperative MDCT angiography

Procedure: D3 resection

Interventions

D3 resectionPROCEDURE

Radical D3 resection of the right colon through the use of preoperative MDCT angiography

D3 resection

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histo-pathologically verified adeno-carcinoma of the right colon
  • Patients under the age of 75
  • Patients medically cleared by anesthesiologist for general anesthesia
  • Signed informed consent form

You may not qualify if:

  • Patients with recurrent cancer after previous surgery
  • Patients with distant metastasis
  • Patients who are not medically cleared to undergo anesthesia
  • Patients who do not sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Lorenskog, 1478, Norway

RECRUITING

Vestfold Hospital Trust

Tønsberg, 3103, Norway

RECRUITING

Related Publications (2)

  • Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Nesgaard JM, Benth JS, Ignjatovic D; R. C. C. study group. Comparing 5-Year Survival Rates Before and After Re-stratification of Stage I-III Right-Sided Colon Cancer Patients by Establishing the Presence/Absence of Occult Tumor Cells and Lymph Node Metastases in the Different Levels of Surgical Dissection. J Gastrointest Surg. 2022 Oct;26(10):2201-2211. doi: 10.1007/s11605-022-05434-6. Epub 2022 Aug 29.

    PMID: 36036877DERIVED

  • Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Benth JS, Ignjatovic D; RCC study group. Interactions of occult tumor spread and surgical technique on overall and disease-free survival in patients operated for stage I and II right-sided colon cancer. J Cancer Res Clin Oncol. 2021 Dec;147(12):3535-3543. doi: 10.1007/s00432-021-03773-6. Epub 2021 Aug 24.

    PMID: 34427788DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dejan Ignjatovic, MD, PhD

CONTACT

+4746681797dexexer01@hotmail.com

Bojan Stimec, MD, PhD

CONTACT

bojan.stimec@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 11, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

NO(2)