Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
D3/CME
Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
1 other identifier
interventional
128
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 3, 2024
May 1, 2024
5.4 years
December 6, 2018
May 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complications
Surgical and general complications by Clavien-Dindo Classification og surgical complications
30 days
Secondary Outcomes (8)
Surgical quality vascular resection
6 months
Surgical quality lymph nodes
6 months
Patient outcome general
6 months
Patient outcome bowel function
6 months
Oncological outcome survival
60 months
- +3 more secondary outcomes
Other Outcomes (6)
Compare the D3 specimen with the CME specimen morphologically
4 weeks
Operative parameters time
1 day
Operative parameters blood loss
1 day
- +3 more other outcomes
Study Arms (2)
Open D3
EXPERIMENTALRight colectomy Open surgery Central lymphadenectomy and vascular ligation
Laparoscopic CME with CVL
ACTIVE COMPARATORRight colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with recurrent cancer after previous surgery
- Patients with synchronous distant metastasis
- Patients with ongoing oncological treatment due to other cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haraldsplass Deaconess Hospitallead
- Helse-Bergen HFcollaborator
- University of Bergencollaborator
Study Sites (1)
Haraldsplass
Bergen, 5021, Norway
Related Publications (2)
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.
PMID: 38242575DERIVEDLygre 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.
PMID: 37643373DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kristin B. Lygre, M.D
Haraldsplass Deaconess Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Doctor
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 14, 2018
Study Start
September 1, 2016
Primary Completion
January 31, 2022
Study Completion (Estimated)
December 31, 2026
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share