Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

Quality of Life Clinical Trial

Official title:

Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670574
• Other study ID #: 2016/1286
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Sykehuset i Vestfold HF
• Contact: Dejan Ignjatovic, MD PhD
• Phone: +4767969895
• Email: dejan.ignjatovic[@]ahus.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Lymph Node Metastases
• Lymphatic Metastasis
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Quality of Life
• Small Bowel Cancer
• Small Bowel Carcinoid Tumor
• Tumor Metastasis

Intervention

Procedure:
• Surgery with extended (D3) mesenterectomy for small bowel tumors

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (5)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	CarciNor, Helse Sor-Ost, Oslo University Hospital, University of Geneva, Switzerland

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lymph nodes in total in D2 and D3 areas		1 month
Primary	Number of positive lymph nodes in D2 and D3 areas		1 month
Secondary	Complications		30 days
Secondary	Peroperative blood loss		30 days
Secondary	Hospitalization time		1-90 days
Secondary	Operation time		Intraoperative
Secondary	Tumor type		30 days
Secondary	Presence and size of mesenteric mass		30 days
Secondary	Resection type and -margins		30 days
Secondary	30-day mortality		30 days
Secondary	2-year follow-up		2 years
Secondary	5-year follow-up		5 years