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

Quality of Life Clinical Trial

— D3/CME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03776591
• Other study ID #: REK 2015/2396
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Haraldsplass Deaconess Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 31, 2026
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colonic Neoplasms
• Complication
• Lymph Node Metastases
• Lymphatic Metastasis
• Neoplastic Cells, Circulating
• Quality of Life
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Open surgery

• Right colectomy

• Laparoscopic surgery

• Central lymphadenectomy and vascular ligation

Locations

Country	Name	City	State
Norway	Haraldsplass	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital	Helse-Bergen HF, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the D3 specimen with the CME specimen morphologically	West classification	4 weeks
Other	Operative parameters time	Operating time in minutes	1 day
Other	Operative parameters blood loss	Intraoperative blood loss in ml	1 day
Other	Operative parameters bleeding	Incidents of bleeding from central vascular structures; yes/no	1 day
Other	Postoperative parameters	Incisional hernias; yes/no	6 months
Other	Hospitalization	Total length of stay, including readmissions within 30 days	30 days
Primary	Complications	Surgical and general complications by Clavien-Dindo Classification og surgical complications	30 days
Secondary	Surgical quality vascular resection	Vascular stump length in mm	6 months
Secondary	Surgical quality lymph nodes	Number of lymph nodes	6 months
Secondary	Patient outcome general	15D Health-related quality of life (HRQoL) preoperative and at 6 months. Scale 0-1. a higher score reflects a better HRQoL	6 months
Secondary	Patient outcome bowel function	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.	6 months
Secondary	Oncological outcome survival	Survival in months	60 months
Secondary	Oncological outcome recurrence	Time to recurrence in months	60 months
Secondary	Prognostic significance of ctDNA	copies/mL plasma or % fractional abundance (mutant/total ctDNA)	60 months
Secondary	Prognostic significance of CTCs	CTC/ml blood	60 months