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Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer (D3/CME)

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ClinicalTrials.gov Identifier: NCT03776591
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
Helse-Bergen HF
University of Bergen
Information provided by (Responsible Party):
Kristin Bentung Lygre, Haraldsplass Deaconess Hospital

Brief Summary:

The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome.

The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).


Condition or disease Intervention/treatment Phase
Complication Quality of Life Surgical Procedure, Unspecified Lymph Node Metastases Circulating Tumor Cell Procedure: Open surgery Procedure: Right colectomy Procedure: Laparoscopic surgery Procedure: Central lymphadenectomy and vascular ligation Not Applicable

Detailed Description:

This is a prospective, randomized, multi-center clinical study. The short term outcome, 2 and 5 year survival and mortality rates will be compared between the groups operated with open D3 resection at Haukeland University hospital and laparoscopic CME with CVL right hemicolectomy at Haraldsplass Deaconess hospital. Computer generated block randomization will be used.

All patients ≤ 85 years with tumor localized in the right colon will be considered to participate in the study. The patients will be summoned to the first consultation to the hospital they are referred to. They will be informed of the study. A patient who meets the inclusion criteria will be asked to participate in the study and sign the informed consent. A patient who accepts will be assigned a sequential participant number and then referred to open D3 or laparoscopic CME (right hemicolectomy) according to a pre-specified randomized list of treatments.

All patients referred with right sided colon cancer in the inclusion period will be registered, and the reason why some do not participate in the study will be documented. Patients who decline to participate in the study will be assigned standard treatment in the institution they are referred to.

Blood samples for analysis of ctDNA/CTCs will be collected preoperatively, 3-10th postoperative day, at 3 months and at each check the next five years at six months intervals. All sample times except the first postoperative control, correspond to the time of CEA and CT in ordinary follow-up. Proteomic technology based analysis of tumor tissue


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025

Arm Intervention/treatment
Experimental: Open D3
Right colectomy Open surgery Central lymphadenectomy and vascular ligation
Procedure: Open surgery
Procedure: Right colectomy
Procedure: Central lymphadenectomy and vascular ligation
Active Comparator: Laparoscopic CME with CVL
Right colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation
Procedure: Right colectomy
Procedure: Laparoscopic surgery
Procedure: Central lymphadenectomy and vascular ligation



Primary Outcome Measures :
  1. Complications [ Time Frame: 30 days ]
    Surgical and general complications by Clavien-Dindo Classification og surgical complications


Secondary Outcome Measures :
  1. Surgical quality vascular resection [ Time Frame: 6 months ]
    Vascular stump length in mm

  2. Surgical quality lymph nodes [ Time Frame: 6 months ]
    Number of lymph nodes

  3. Patient outcome general [ Time Frame: 6 months ]
    15D Health-related quality of life (HRQoL) preoperative and at 6 months. Scale 0-1. a higher score reflects a better HRQoL

  4. Patient outcome bowel function [ Time Frame: 6 months ]
    Quality of life (LARS (low anterior resection syndrome) score preoperative and at 6 months. Scale 0-42, where 0 reflects no LARS and 30-42 major LARS.

  5. Oncological outcome survival [ Time Frame: 60 months ]
    Survival in months

  6. Oncological outcome recurrence [ Time Frame: 60 months ]
    Time to recurrence in months

  7. Prognostic significance of ctDNA [ Time Frame: 60 months ]
    copies/mL plasma or % fractional abundance (mutant/total ctDNA)

  8. Prognostic significance of CTCs [ Time Frame: 60 months ]
    CTC/ml blood


Other Outcome Measures:
  1. Compare the D3 specimen with the CME specimen morphologically [ Time Frame: 4 weeks ]
    West classification

  2. Operative parameters time [ Time Frame: 1 day ]
    Operating time in minutes

  3. Operative parameters blood loss [ Time Frame: 1 day ]
    Intraoperative blood loss in ml

  4. Operative parameters bleeding [ Time Frame: 1 day ]
    Incidents of bleeding from central vascular structures; yes/no

  5. Postoperative parameters [ Time Frame: 6 months ]
    Incisional hernias; yes/no

  6. Hospitalization [ Time Frame: 30 days ]
    Total length of stay, including readmissions within 30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients with malignant tumor of the right colon (cecum, ascending colon, right flexure and right transverse) at CT, colonoscopy.

    • Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection
    • Patients ≤ 85 years
    • Signed informed consent form

Exclusion Criteria:

  • • Patients with recurrent cancer after previous surgery

    • Patients with synchronous distant metastasis
    • Patients with ongoing oncological treatment due to other cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776591


Contacts
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Contact: Kristin B Lygre, M.D 004755978500 kristin.bentung.lygre@haraldsplass.no
Contact: Frank Pfeffer, Ph.D 004755975000 frank.pfeffer@helse-bergen.no

Locations
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Norway
Haraldsplass Recruiting
Bergen, Norway, 5021
Contact: Kristin B Lygre, M.D         
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
Helse-Bergen HF
University of Bergen
Investigators
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Study Director: Kristin B. Lygre, M.D Haraldsplass Deaconess Hospital

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Responsible Party: Kristin Bentung Lygre, Consultant Doctor, Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier: NCT03776591     History of Changes
Other Study ID Numbers: REK 2015/2396
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kristin Bentung Lygre, Haraldsplass Deaconess Hospital:
D3 lymphadenectomy
Right-sided
Colon cancer
Complications
Circulating tumor cells
Circulating DNA (cDNA)
Laparoscopy
Complete mesocolic excision

Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplastic Cells, Circulating
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes