Small Bowel CancerNCT05670574
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
A study testing Surgery with extended (D3) mesenterectomy for small bowel tumors in people with Small Bowel Cancer and Small Bowel Carcinoid Tumor, run by Sykehuset i Vestfold HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Cancer, Small Bowel Carcinoid Tumor, Quality of Life
- What is being tested?
- Surgery with extended (D3) mesenterectomy for small bowel tumors
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 4 Nov 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Extraduodenal small bowel tumors verified as GIST or benign tumor
- Widespread lymphoma
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lorenskog, 1478
Dejan Ignjatovic, MD, PhD, dexexer01@hotmail.com
About this study
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.
Read the 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
- Being tested
- Surgery with extended (D3) mesenterectomy for small bowel tumors
- Keywords
- Small bowel cancer, Extended mesenterectomy, Lymph node metastases, Tumor feeding vessel, Quality of life
- Medical subject headings
- Lymphatic Metastasis, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with extended (D3) mesenterectomy for small bowel tumorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lymph nodes in total in D2 and D3 areas
Measured: 1 month
Number of positive lymph nodes in D2 and D3 areas
Measured: 1 month
Secondary outcomes (10)
Complications
Measured: 30 days
Peroperative blood loss
Measured: 30 days
Hospitalization time
Measured: 1-90 days
Operation time
Measured: Intraoperative
Tumor type
Measured: 30 days
Presence and size of mesenteric mass
Measured: 30 days
Resection type and -margins
Measured: 30 days
30-day mortality
Measured: 30 days
2-year follow-up
Measured: 2 years
5-year follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start4 Nov 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small Bowel CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, University of Geneva, Switzerland, Oslo University Hospital, CarciNor
- Responsible party
- Principal investigator, Dejan Ignjatovic, University Hospital, Akershus
- Investigators
- Dejan Ignjatovic, MD PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670574
- Sponsor's protocol ID
- 2016/1286
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40624418Vasic 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.
PubMed 39936801
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
- ClinicalTrials.gov ID
- NCT05670574
- Acronym / sponsor ID
- 2016/1286
- Conditions
- Small Bowel Cancer, Small Bowel Carcinoid Tumor, Quality of Life, Lymph Node Metastases, Tumor Metastasis
- Keywords
- Small bowel cancer, Extended mesenterectomy, Lymph node metastases, Tumor feeding vessel, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Helse Sor-Ost, University of Geneva, Switzerland, Oslo University Hospital, CarciNor
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Extraduodenal small bowel tumors verified as GIST or benign tumor
- Widespread lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with extended (D3) mesenterectomy for small bowel tumors | Procedure or surgery | – |
Primary outcome
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 40624418Vasic 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.
- Derived from this study: PubMed 39936801Vasic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan Ignjatovic, MD PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with extended (D3) mesenterectomy for small bowel tumors in people with Small Bowel Cancer and Small Bowel Carcinoid Tumor, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dejan Ignjatovic, MD PhD (+4767969895, dejan.ignjatovic@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lymph nodes in total in D2 and D3 areas (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.