Clinical trial NCT05670574: Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
Official title: Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: University of Geneva, Switzerland
name: Oslo University Hospital
name: CarciNor
First posted: 2023-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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" section
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of lymph nodes in total in D2 and D3 areas
timeFrame: 1 month
measure: Number of positive lymph nodes in D2 and D3 areas
timeFrame: 1 month
Secondary outcomes:
measure: Complications
timeFrame: 30 days
measure: Peroperative blood loss
timeFrame: 30 days
measure: Hospitalization time
timeFrame: 1-90 days
measure: Operation time
timeFrame: Intraoperative
measure: Tumor type
timeFrame: 30 days
measure: Presence and size of mesenteric mass
timeFrame: 30 days
measure: Resection type and -margins
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: 2-year follow-up
timeFrame: 2 years
measure: 5-year follow-up
timeFrame: 5 years
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Dejan Ignjatovic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: