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

NCT ID: NCT03776591

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2026-12-31

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

Conditions

Complication; Quality of Life; Surgical Procedure, Unspecified; Lymph Node Metastases; Circulating Tumor Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open D3

Right colectomy Open surgery Central lymphadenectomy and vascular ligation

Group Type: EXPERIMENTAL

Open surgery

Intervention Type: PROCEDURE

Right colectomy

Intervention Type: PROCEDURE

Central lymphadenectomy and vascular ligation

Intervention Type: PROCEDURE

Laparoscopic CME with CVL

Right colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation

Group Type: ACTIVE_COMPARATOR

Right colectomy

Intervention Type: PROCEDURE

Laparoscopic surgery

Intervention Type: PROCEDURE

Central lymphadenectomy and vascular ligation

Intervention Type: PROCEDURE

Interventions

Open surgery

Intervention Type: PROCEDURE

Right colectomy

Intervention Type: PROCEDURE

Laparoscopic surgery

Intervention Type: PROCEDURE

Central lymphadenectomy and vascular ligation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse-Bergen HF

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Haraldsplass Deaconess Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristin Bentung Lygre

Consultant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin B. Lygre, M.D

Role: STUDY_DIRECTOR

Haraldsplass Deaconess Hospital

Locations

Haraldsplass

Bergen, , Norway

Countries

Norway

References

Lygre KB, Forthun RB, Hoysaeter T, Hjelle SM, Eide GE, Gjertsen BT, Pfeffer F, Hovland R. Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study. BJS Open. 2024 Jan 3;8(1):zrad146. doi: 10.1093/bjsopen/zrad146.

Reference Type: DERIVED

PMID: 38242575 (View on PubMed)

Lygre KB, Eide GE, Forsmo HM, Dicko A, Storli KE, Pfeffer F. Complications after open and laparoscopic right-sided colectomy with central lymphadenectomy for colon cancer: randomized controlled trial. BJS Open. 2023 Jul 10;7(4):zrad074. doi: 10.1093/bjsopen/zrad074.

Reference Type: DERIVED

PMID: 37643373 (View on PubMed)

Other Identifiers

REK 2015/2396

Identifier Type: -

Identifier Source: org_study_id