Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

Sponsor

Sykehuset i Vestfold HF (Other)

Overall Status

Recruiting

CT.gov ID

NCT05670574

Collaborator

Helse Sor-Ost (Other), University of Geneva, Switzerland (Other), Oslo University Hospital (Other), CarciNor (Other)

150

Enrollment

Location

109.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Cancer Small Bowel Carcinoid Tumor Quality of Life Lymph Node Metastases Tumor Metastasis	Procedure: Surgery with extended (D3) mesenterectomy for small bowel tumors	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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" sectionTesting 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)

Primary Purpose:

Treatment

Official Title:

Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

Actual Study Start Date :

Nov 4, 2016

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

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]
30-day mortality [30 days]
2-year follow-up [2 years]
5-year follow-up [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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