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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 14, 2018
Sponsor:
Collaborators:
Helse-Bergen HF
University of Bergen
Information provided by (Responsible Party):
Kristin Bentung Lygre, Haraldsplass Deaconess Hospital

December 6, 2018
December 14, 2018
December 14, 2018
September 1, 2016
September 1, 2025   (Final data collection date for primary outcome measure)
Complications [ Time Frame: 30 days ]
Surgical and general complications by Clavien-Dindo Classification og surgical complications
Same as current
No Changes Posted
  • Surgical quality vascular resection [ Time Frame: 6 months ]
    Vascular stump length in mm
  • Surgical quality lymph nodes [ Time Frame: 6 months ]
    Number of lymph nodes
  • Patient outcome general [ Time Frame: 6 months ]
    Quality of life (15D score) preoperative and at 6 months
  • Patient outcome bowel function [ Time Frame: 6 months ]
    Quality of life (LARS (low anterior resection score)) preoperative and at 6 months
  • Oncological outcome survival [ Time Frame: 60 months ]
    Survival in months
  • Oncological outcome recurrence [ Time Frame: 60 months ]
    Time to recurrence in months
  • Prognostic significance of ctDNA [ Time Frame: 60 months ]
    copies/mL plasma or % fractional abundance (mutant/total ctDNA)
  • Prognostic significance of CTCs [ Time Frame: 60 months ]
    CTC/ml blood
Same as current
  • Compare the D3 specimen with the CME specimen morphologically [ Time Frame: 4 weeks ]
    West classification
  • Operative parameters time [ Time Frame: 1 day ]
    Operating time in minutes
  • Operative parameters blood loss [ Time Frame: 1 day ]
    Intraoperative blood loss in ml
  • Operative parameters bleeding [ Time Frame: 1 day ]
    Incidents of bleeding from central vascular structures; yes/no
  • Postoperative parameters [ Time Frame: 6 months ]
    Incisional hernias; yes/no
  • Hospitalization [ Time Frame: 30 days ]
    Total length of stay, including readmissions within 30 days
Same as current
 
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study

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).

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

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
  • Experimental: Open D3
    Right colectomy Open surgery Central lymphadenectomy and vascular ligation
    Interventions:
    • 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
    Interventions:
    • Procedure: Right colectomy
    • Procedure: Laparoscopic surgery
    • Procedure: Central lymphadenectomy and vascular ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
218
Same as current
September 1, 2025
September 1, 2025   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact: Kristin B Lygre, M.D 004755978500 kristin.bentung.lygre@haraldsplass.no
Contact: Frank Pfeffer, Ph.D 004755975000 frank.pfeffer@helse-bergen.no
Norway
 
 
NCT03776591
REK 2015/2396
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Kristin Bentung Lygre, Haraldsplass Deaconess Hospital
Haraldsplass Deaconess Hospital
  • Helse-Bergen HF
  • University of Bergen
Study Director: Kristin B. Lygre, M.D Haraldsplass Deaconess Hospital
Haraldsplass Deaconess Hospital
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP