Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Small Bowel Cancer; Lymph Node Metastases; Small Bowel Carcinoid Tumor; Tumor Metastasis
• Intervention / Treatment: Procedure: Surgery with extended (D3) mesenterectomy for small bowel tumors

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dejan Ignjatovic, MD PhD; Phone Number: +4767969895; Email: dejan.ignjatovic@ahus.no
• Study Contact Backup: Name: Erik Kjæstad, MD; Phone Number: +4767964435; Email: erik.kjaestad@ahus.no

Study Locations

• Norway
  • Lorenskog, Norway, 1478
    • Recruiting
    • Akershus University Hospital
    • Contact: Dejan Ignjatovic, MD, PhD; Email: dexexer01@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of lymph nodes in total in D2 and D3 areas	1 month
Number of positive lymph nodes in D2 and D3 areas	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
30-day mortality	30 days
Complications	30 days
Peroperative blood loss	30 days
Hospitalization time	1-90 days
Operation time	Intraoperative
Tumor type	30 days
Presence and size of mesenteric mass	30 days
Resection type and -margins	30 days
2-year follow-up	2 years
5-year follow-up	5 years

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF
• Collaborators: Oslo University Hospital; Helse Sor-Ost; University of Geneva, Switzerland; CarciNor
• Investigators: Principal Investigator: Dejan Ignjatovic, MD PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Small bowel cancer; Extended mesenterectomy; Lymph node metastases; Tumor feeding vessel
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis; Neoplasms, Second Primary; Carcinoid Tumor
• Other Study ID Numbers: 2016/1286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No