Surgery for small bowel tumors with extended lymph node removal
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
This study is testing a specific type of surgery for small bowel tumors to see if removing more lymph nodes safely helps patients recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sykehuset i Vestfold HF Academic / other |
| Locations | 1 site (Lorenskog) |
| Trial ID | NCT05670574 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of central D3 lymphadenectomy in patients with small bowel tumors. It aims to standardize surgical techniques for lymph node dissection, which currently vary widely. The study includes prospective patients undergoing surgery, with a focus on preoperative vascular mapping to personalize the surgical approach. Key outcomes include the number of lymph nodes removed, complications, and patient recovery over 2- and 5-year follow-ups.
Who should consider this trial
Good fit: Ideal candidates are patients with verified extraduodenal tumors in the small bowel who are fit for surgery and can provide informed consent.
Not a fit: Patients with benign tumors or widespread lymphoma may not benefit from this surgical approach.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with small bowel cancer.
How similar studies have performed: While there is strong evidence supporting radical lymphadenectomy for certain tumor types, this specific approach is still under debate and may be considered novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lorenskog
- Akershus University Hospital — Lorenskog, Norway (Recruiting)
Study contacts
- Principal investigator: Dejan Ignjatovic, MD PhD — University Hospital, Akershus
- Study coordinator: Dejan Ignjatovic, MD PhD
- Email: dejan.ignjatovic@ahus.no
- Phone: +4767969895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.