Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

NCT ID: NCT05670574

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-04
• Study Completion Date: 2025-12-31

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

Conditions

Small Bowel Cancer; Small Bowel Carcinoid Tumor; Quality of Life; Lymph Node Metastases; Tumor Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Surgery with extended (D3) mesenterectomy for small bowel tumors

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Sor-Ost

OTHER_GOV

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

CarciNor

UNKNOWN

Sponsor Role: collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role: lead

Responsible Party

Dejan Ignjatovic

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dejan Ignjatovic, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lorenskog, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Dejan Ignjatovic, MD PhD

Role: CONTACT

dejan.ignjatovic@ahus.no

+4767969895

Erik Kjæstad, MD

Role: CONTACT

erik.kjaestad@ahus.no

+4767964435

Facility Contacts

Dejan Ignjatovic, MD, PhD

Role: primary

dexexer01@hotmail.com

References

Vasic T, Stimec M, Stimec BV, Edwin B, Ignjatovic D. Lymphatic and vascular anatomy define surgical principles for radical treatment of distal duodenal and proximal jejunal tumors. Surg Endosc. 2025 Aug;39(8):5421-5429. doi: 10.1007/s00464-025-11909-9. Epub 2025 Jul 7.

Reference Type: DERIVED

PMID: 40624418 (View on PubMed)

Vasic T, Stimec MB, Stimec BV, Kjaestad E, Ignjatovic D. Jejunal Lymphatic and Vascular Anatomy Defines Surgical Principles for Treatment of Jejunal Tumors. Dis Colon Rectum. 2025 May 1;68(5):553-561. doi: 10.1097/DCR.0000000000003644. Epub 2025 Feb 12.

Reference Type: DERIVED

PMID: 39936801 (View on PubMed)

Other Identifiers

2016/1286

Identifier Type: -

Identifier Source: org_study_id