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

Tracking Information
First Submitted Date ICMJE	December 6, 2018
First Posted Date ICMJE	December 14, 2018
Last Update Posted Date	December 14, 2018
Actual Study Start Date ICMJE	September 1, 2016
Estimated Primary Completion Date	September 1, 2025 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 13, 2018)	Complications [ Time Frame: 30 days ]; Surgical and general complications by Clavien-Dindo Classification og surgical complications
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: December 13, 2018)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: December 13, 2018)	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
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Official Title ICMJE	Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
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
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Complication; Quality of Life; Surgical Procedure, Unspecified; Lymph Node Metastases; Circulating Tumor Cell
Intervention ICMJE	Procedure: Open surgery; Procedure: Right colectomy; Procedure: Laparoscopic surgery; Procedure: Central lymphadenectomy and vascular ligation
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: December 13, 2018)	218
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 1, 2025
Estimated Primary Completion Date	September 1, 2025 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Kristin B Lygre, M.D 004755978500 kristin.bentung.lygre@haraldsplass.no Contact: Frank Pfeffer, Ph.D 004755975000 frank.pfeffer@helse-bergen.no
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03776591
Other Study ID Numbers ICMJE	REK 2015/2396
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Kristin Bentung Lygre, Haraldsplass Deaconess Hospital
Study Sponsor ICMJE	Haraldsplass Deaconess Hospital
Collaborators ICMJE	Helse-Bergen HF; University of Bergen
Investigators ICMJE	Study Director: Kristin B. Lygre, M.D Haraldsplass Deaconess Hospital
PRS Account	Haraldsplass Deaconess Hospital
Verification Date	December 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP