An interventional study of Surgery with extended (D3) mesenterectomy for small bowel tumors in Small Bowel Cancer, Small Bowel Carcinoid Tumor and Quality of Life, sponsored by Sykehuset i Vestfold HF. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Sykehuset i Vestfold HF · Not applicable, Interventional, and Treatment
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.
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
213 studies on the registry are indexed under Lymphatic Metastasis; 77 are open to participants now.
This study's planned enrollment of 150 is above the median of 97 across 109 interventional studies indexed under Lymphatic Metastasis.
Browse Lymphatic Metastasis studies →Sykehuset i Vestfold HF is the lead sponsor of 23 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of lymph nodes in total in D2 and D3 areas
Time frame: 1 month
Number of positive lymph nodes in D2 and D3 areas
Time frame: 1 month
Complications
Time frame: 30 days
Peroperative blood loss
Time frame: 30 days
Hospitalization time
Time frame: 1-90 days
Operation time
Time frame: Intraoperative
Tumor type
Time frame: 30 days
Presence and size of mesenteric mass
Time frame: 30 days
Resection type and -margins
Time frame: 30 days
30-day mortality
Time frame: 30 days
2-year follow-up
Time frame: 2 years
5-year follow-up
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Dec 2025, 109 months after the start.
Of 50 interventional studies with no phase under Lymphatic Metastasis, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 98. This study's planned 109 months is above that.
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Sykehuset i Vestfold HF