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

NCT ID: NCT01351714

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D3 resection

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

Group Type OTHER

D3 resection

Intervention Type PROCEDURE

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

Interventions

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D3 resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role lead

Responsible Party

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Dejan Ignjatovic

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akershus University Hospital

Lorenskog, , Norway

Site Status RECRUITING

Vestfold Hospital Trust

Tønsberg, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Dejan Ignjatovic, MD, PhD

Role: CONTACT

+4746681797

Bojan Stimec, MD, PhD

Role: CONTACT

Facility Contacts

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Dejan Ignjatovic, MD, PhD

Role: primary

Jens Marius Nesgaard, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36036877 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34427788 (View on PubMed)

Other Identifiers

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D3 MDCT angio

Identifier Type: -

Identifier Source: org_study_id

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