NCT03776591: D3/CME

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

Active, enrolled NA Last updated 3 May 2024

What this trial tests

NA trial testing Open surgery in Complication in 128 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2016

Primary endpoint
31 January 2022

31 December 2026

Quick facts

Lead sponsor	Haraldsplass Deaconess Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	1 September 2016
Primary completion	31 January 2022
Estimated completion	31 December 2026
Sites	1 location across Norway

Drugs / interventions tested

• Open surgery
• Right colectomy
• Laparoscopic surgery
• Central lymphadenectomy and vascular ligation

Conditions studied

• Complication — all drugs for Complication →
• Quality of Life — all drugs for Quality of Life →
• Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →
• Lymph Node Metastases — all drugs for Lymph Node Metastases →

Sponsor

Haraldsplass Deaconess Hospital

Who can join

Adults 18 to 85, any sex, with Complication or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Is Laparoscopic Complete Mesocolic Excision and Central Vascular Ligation Really Necessary for All Patients With Right-Sided Colon Cancer?
   Son GM, Lee IY, Lee YS, Kye BH, et al · · 2021 · cited 19× · PMID 34875818 · DOI 10.3393/ac.2021.00955.0136
2. Liquid biopsies for colorectal cancer: a narrative review of ongoing clinical trials and the current use of this technology at a comprehensive cancer center.
   Broccard SP, Kasbi AA, Bagaria SP, Jones J, et al · · 2022 · cited 8× · PMID 35284120 · DOI 10.21037/jgo-21-470
3. Complications after open and laparoscopic right-sided colectomy with central lymphadenectomy for colon cancer: randomized controlled trial.
   Lygre KB, Eide GE, Forsmo HM, Dicko A, et al · · 2023 · cited 7× · PMID 37643373 · DOI 10.1093/bjsopen/zrad074
4. Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study.
   Lygre KB, Forthun RB, Høysæter T, Hjelle SM, et al · · 2024 · cited 6× · PMID 38242575 · DOI 10.1093/bjsopen/zrad146
5. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
6. The Method of Minimal Residual Disease Detection With Circulating Tumor DNA and Its Clinical Applications in Colorectal Cancer.
   Liu M, Mu T, Gu J, Xu M, et al · · 2025 · cited 2× · PMID 40033897 · DOI 10.1002/cnr2.70167