Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
Primary Purpose
Small Bowel Cancer, Small Bowel Carcinoid Tumor, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Surgery with extended (D3) mesenterectomy for small bowel tumors
Sponsored by
About this trial
This is an interventional treatment trial for Small Bowel Cancer focused on measuring Small bowel cancer, Extended mesenterectomy, Lymph node metastases, Tumor feeding vessel, Quality of life
Eligibility Criteria
Inclusion Criteria: Patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up Radiologically/scintigraphically/histologically verified extraduodenal tumor(-s) in the small bowel and/or in the mesentery of the small bowel No signs of inoperability Fit for general anesthetics Exclusion Criteria: Extraduodenal small bowel tumors verified as GIST or benign tumor Widespread lymphoma
Sites / Locations
- Akershus University HospitalRecruiting
Outcomes
Primary Outcome Measures
Number of lymph nodes in total in D2 and D3 areas
Number of positive lymph nodes in D2 and D3 areas
Secondary Outcome Measures
Complications
Peroperative blood loss
Hospitalization time
Operation time
Tumor type
Presence and size of mesenteric mass
Resection type and -margins
30-day mortality
2-year follow-up
5-year follow-up
Full Information
NCT ID
NCT05670574
First Posted
January 2, 2023
Last Updated
January 3, 2023
Sponsor
Sykehuset i Vestfold HF
Collaborators
Helse Sor-Ost, University of Geneva, Switzerland, Oslo University Hospital, CarciNor
1. Study Identification
Unique Protocol Identification Number
NCT05670574
Brief Title
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
Official Title
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
Helse Sor-Ost, University of Geneva, Switzerland, Oslo University Hospital, CarciNor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to investigate the safety and efficacy of central D3 lymphadenectomy in cases of small bowel tumors. Such dissection is under debate; consensus guidelines are vague when it comes to surgical techniques and practice is highly variable.
Detailed Description
Cancer of the small intestine is rare. Consensus practice on surgical technique have been difficult to reach, both on lymph node dissection level and on strategic choices according to tumor localization and -type. Evidence is strong for systematic and radical lymphadenectomy for neuroendocrine tumors (NET) and adenocarcinomas. This study includes a series of prospective and consecutive patients operated with central (D3) lymphadenectomy. Key points are preoperative mapping of vascular anatomy to facilitate personalized surgery with radical lymphadenectomy to the mesenterial root, both anterior and posterior to the superior mesenteric vessels. Three different surgical techniques (plus one subgroup) are used, and will be reported on, according to tumor localization and -type. Complications, perioperative morbidity and mortality, operating time and length of hospital stay will be noted, as well as tumor types, number of tumors, mesenteric mass size, resection types and margins, and the anatomical distribution of tumors. Patient outcome during 2- and 5-year follow up will be reported. We will investigate the accuracy of the preoperative vascular anatomy reconstructions and eventual procedure-specific complications. Still, the main outcome measures are the lymph node yield: number of lymph nodes gained in the D2 and D3 areas.
Patients are included in the study "Safe extended (D3) mesenterectomy for small bowel tumors" - REK number 19898. Patients are given an informed consent formula. Inclusion criteria are patients with small bowel tumor(s) of probable or confirmed neoplastic nature capable of consent and without general inoperability properties. The ENETS Neuroendocrine Tumor Centre of Excellence at Oslo University Hospital approves and recommends surgery for patients with NET. All patients shall have their mesenterial vascular anatomy reconstructed in 3D preoperatively, for both arteries and veins. The reconstruction is made by manual segmentation based on biphasic CT scans of their abdomens.
The surgical-oncological aim is the same for both open and minimally invasive access surgery: an intact and continuous specimen with tumor and mesentery in one piece including unbroken and correct anatomical tissue planes. We define the D3 volume to include all lipolymphatic tissue anterior and posterior to the superior mesenteric vessels limited by arterial and venous branches to and from the tumor-bearing segment of bowel. Dissection is made along the blood vessels cranially and caudally. Mesenteric nodal masses and fibrosis and desmoplasia are carefully dissected from the underlying blood vessels to be saved by exposing and dividing the vessel sheets
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Cancer, Small Bowel Carcinoid Tumor, Quality of Life, Lymph Node Metastases, Tumor Metastasis
Keywords
Small bowel cancer, Extended mesenterectomy, Lymph node metastases, Tumor feeding vessel, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Testing three new surgical techniques for small bowel tumors. Tumor feeding vessel and vascular anatomy of each patients is identified preoperatively on CT scan and based on this we produce a 3D reconstruction. Based on tumor location we choose one of the three techniques and perform extended D3 mesenterectomy. The results will be reported on as described in the "project description" section
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Surgery with extended (D3) mesenterectomy for small bowel tumors
Primary Outcome Measure Information:
Title
Number of lymph nodes in total in D2 and D3 areas
Time Frame
1 month
Title
Number of positive lymph nodes in D2 and D3 areas
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Complications
Time Frame
30 days
Title
Peroperative blood loss
Time Frame
30 days
Title
Hospitalization time
Time Frame
1-90 days
Title
Operation time
Time Frame
Intraoperative
Title
Tumor type
Time Frame
30 days
Title
Presence and size of mesenteric mass
Time Frame
30 days
Title
Resection type and -margins
Time Frame
30 days
Title
30-day mortality
Time Frame
30 days
Title
2-year follow-up
Time Frame
2 years
Title
5-year follow-up
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up
Radiologically/scintigraphically/histologically verified extraduodenal tumor(-s) in the small bowel and/or in the mesentery of the small bowel
No signs of inoperability
Fit for general anesthetics
Exclusion Criteria:
Extraduodenal small bowel tumors verified as GIST or benign tumor
Widespread lymphoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dejan Ignjatovic, MD PhD
Phone
+4767969895
Email
dejan.ignjatovic@ahus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Kjæstad, MD
Phone
+4767964435
Email
erik.kjaestad@ahus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Ignjatovic, MD PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejan Ignjatovic, MD, PhD
Email
dexexer01@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
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