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NCT Number: NCT03776591

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

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).

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Key information

Conditions

Complication Circulating Tumor Cell Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Metastases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Surgical Procedure, Unspecified

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haraldsplass

Bergen, 5021, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Surgery

Procedure

Right colectomy

Procedure

Laparoscopic surgery

Procedure

Central lymphadenectomy and vascular ligation

Procedure

Primary outcomes

  1. Complications

    Time frame: 30 days

    Surgical and general complications by Clavien-Dindo Classification og surgical complications

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Haraldsplass Deaconess Hospital

Other

Collaborators

  • Helse-Bergen HF
  • University of Bergen

Registry information

Official study title

Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study

Acronym: D3/CME

Important dates

Study start
2016
Primary completion
2022
Study completion
2026
First posted
Dec 14, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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