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Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
D3 resection
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring D3 resection, right colectomy, MDCT angiography, lymphadenectomy, safe, right colon, preoperative

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Akershus University HospitalRecruiting
  • Vestfold Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

D3 resection

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disease free survival 2 and 5 years after initial surgery
One will compare disease free survival at 2 and 5 years between the two groups to see if those more radically operated through D3 resection will have better outcomes.

Full Information

First Posted
May 9, 2011
Last Updated
September 27, 2020
Sponsor
Sykehuset i Vestfold HF
Collaborators
Konya Meram State Hospital, University of Geneva, Switzerland, University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT01351714
Brief Title
Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
Official Title
Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
Konya Meram State Hospital, University of Geneva, Switzerland, University Hospital, Akershus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The Norwegian gastrointestinal cancer group has recommended D3 resection as the standard operative technique for colon cancer. D3 resection implies ligation of the blood vessels at their origin. There is evidence that the recurrence free period and survival improves with the number of lymph nodes harvested at surgery. However, the current practice in Norway, while performing right hemicolectomy for cancer is to ligate the feeding vessels for the right colon on the right hand side of the superior mesenteric vein (SMV). Significant arterial stumps have been demonstrated in patients operated for right colon cancer with this technique (right colic artery and ileocolic artery vascular stumps with an average length of 3.5 cm and 2.5 cm, respectively). This leaves reason to believe that a certain number of central lymph nodes remain after the procedure. The complex anatomical relationship between the right colic artery and ileocolic artery with the superior mesenteric vein make D3 resection demanding, especially if the right colic artery lies posterior to the SMV. These relationships are investigated in detail in postmortem anatomical studies. These studies show that the right colic artery lies most often anterior to the SMV, while the ileocolic artery lies most often posterior to the SMV. Data has also been provided that a CT angiography can verify these relations as well as postmortem anatomical studies in living patients, thus allowing the surgeon to be aware of them prior to surgery. This could prove to be crucial in planning the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
D3 resection, right colectomy, MDCT angiography, lymphadenectomy, safe, right colon, preoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D3 resection
Arm Type
Other
Arm Description
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
Intervention Type
Procedure
Intervention Name(s)
D3 resection
Intervention Description
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
Primary Outcome Measure Information:
Title
Number of additional lymph nodes removed through radical D3 resection
Description
The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Disease free survival 2 and 5 years after initial surgery
Description
One will compare disease free survival at 2 and 5 years between the two groups to see if those more radically operated through D3 resection will have better outcomes.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dejan Ignjatovic, MD, PhD
Phone
+4746681797
Email
dexexer01@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bojan Stimec, MD, PhD
Email
bojan.stimec@gmail.com
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejan Ignjatovic, MD, PhD
Email
dexexer01@hotmail.com
Facility Name
Vestfold Hospital Trust
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Marius Nesgaard, MD
Email
jens.marius.nesgaard@siv.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
36036877
Citation
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.
Results Reference
derived
PubMed Identifier
34427788
Citation
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.
Results Reference
derived

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Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio

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