NCT05670574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2016

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

9.2 years

First QC Date

January 2, 2023

Last Update Submit

January 3, 2023

Conditions

Small Bowel CancerSmall Bowel Carcinoid TumorQuality of LifeLymph Node MetastasesTumor Metastasis

Keywords

Small bowel cancerExtended mesenterectomyLymph node metastasesTumor feeding vesselQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Complications

    30 days

  • Peroperative blood loss

    30 days

  • Hospitalization time

    1-90 days

  • Operation time

    Intraoperative

  • Tumor type

    30 days

  • +5 more secondary outcomes

Interventions

Surgery with extended (D3) mesenterectomy for small bowel tumorsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Extraduodenal small bowel tumors verified as GIST or benign tumor
  • Widespread lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lorenskog, 1478, Norway

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40624418DERIVED

  • 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.

    PMID: 39936801DERIVED

MeSH Terms

Conditions

Lymphatic MetastasisNeoplasm Metastasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dejan Ignjatovic, MD PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dejan Ignjatovic, MD PhD

CONTACT

+4767969895dejan.ignjatovic@ahus.no

Erik Kjæstad, MD

CONTACT

+4767964435erik.kjaestad@ahus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

November 4, 2016

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)