Clinical trial NCT03776591: Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Official title: Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complication
Quality of Life
Surgical Procedure, Unspecified
Lymph Node Metastases
Circulating Tumor Cell
Keywords: D3 lymphadenectomy
Right-sided
Colon cancer
Complications
Circulating tumor cells
Circulating DNA (cDNA)
Laparoscopy
Complete mesocolic excision
Lead sponsor: Haraldsplass Deaconess Hospital
Sponsor class: OTHER
Collaborators: name: Helse-Bergen HF
name: University of Bergen
First posted: 2018-12-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility 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

Primary outcomes:
measure: Complications
timeFrame: 30 days
Secondary outcomes:
measure: Surgical quality vascular resection
timeFrame: 6 months
measure: Surgical quality lymph nodes
timeFrame: 6 months
measure: Patient outcome general
timeFrame: 6 months
measure: Patient outcome bowel function
timeFrame: 6 months
measure: Oncological outcome survival
timeFrame: 60 months
measure: Oncological outcome recurrence
timeFrame: 60 months
measure: Prognostic significance of ctDNA
timeFrame: 60 months
measure: Prognostic significance of CTCs
timeFrame: 60 months
Other outcomes:
measure: Compare the D3 specimen with the CME specimen morphologically
timeFrame: 4 weeks
measure: Operative parameters time
timeFrame: 1 day
measure: Operative parameters blood loss
timeFrame: 1 day
measure: Operative parameters bleeding
timeFrame: 1 day
measure: Postoperative parameters
timeFrame: 6 months
measure: Hospitalization
timeFrame: 30 days
Locations:
city: Bergen
country: Norway
facility: Haraldsplass
Study officials:
affiliation: Haraldsplass Deaconess Hospital
name: Kristin B. Lygre, M.D
role: STUDY_DIRECTOR
References: