Neuroendocrine (NE) TumorsECHO-NETNCT06779708
The Role of Intraoperative Hepatic Ultrasonography in Gastrointestinal or Pancreatic Neuroendocrine Tumor
An observational study of Neuroendocrine (NE) Tumors and Liver Metastasis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Background: Liver metastases are common in patients with neuroendocrine neoplasms, but often underestimated by preoperative imaging. Intraoperative ultrasound (IOUS) is the reference standard for staging of primary and metastatic liver tumors, with a diagnostic accuracy superior to that of CT and MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine (NE) Tumors, Liver Metastasis
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- 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
Study population: The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres (see the Appendix for list of the centres) in the period 2020-2023.
Who may be able to join
- Patients undergoing open or minimally-invasive surgery for primary neuroendocrine gastro-intestinal or pancreatic tumor.
- cM0 tumor at preoperative imaging
- Preoperative staging including abdominal CT and DOTATOC PET-CT
- Age ≥18 years
- No other malignancies in the previous 5 years
Who cannot join
- Preoperative imaging performed >60 days before surgery
- Patient refusal to participate the study
- Incomplete intraoperative hepatic staging (peri-hepatic adhesions, IOUs not available…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECHO-NET Study: Role of Intraoperative Hepatic Ultrasonography in Patients with Gastrointestinal or Pancreatic Neuroendocrine Tumor Without Liver Metastases At Preoperative Imaging
Background: Liver metastases are common in patients with neuroendocrine neoplasms, but often underestimated by preoperative imaging. Intraoperative ultrasound (IOUS) is the reference standard for staging of primary and metastatic liver tumors, with a diagnostic accuracy superior to that of CT and MRI. Rationale: The present study aims to evaluate the contribution of IOUS to staging of liver disease in patients with neuroendocrine tumor candidates for primary tumor resection classified as cM0 at preoperative imaging.
The study will collect a prospective series of 99 patients undegoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023. All patients had to be cM0 tumor at preoperative imaging. Additional inclusion criteria: age>18 years, ability to give the informed consent for study participation; no other malignancies in the previous 5 years; preoperative staging including abdominal CT and DOTATOC PET-CT performed ≤60 days before surgery.
Read more
This prospective observational multicentre study aims to elucidate the proportion of patients with gastro-intestinal or pancreatic neuroendocrine tumor cM0 at preoperative imaging that have intraoperative detection of liver metastases at IOUS.
Primary endpoint:
- Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging
Secondary endpoints:
- Impact of IOUS on the therapeutic strategy
- Performances of preoperative imaging (CT, MRI and PET-CT) in comparison with those of IOUS
The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023.
The study includes the following steps:
Preoperative / enrollment: All patients candidates to resection of gastro-intestinal or pancreatic neuroendocrine tumor will be considered for the study. Only cM0 patients will be enrolled. All patients enrolled in the study must have performed a preoperative abdominal CT scan with contrast medium and a DOTATOC-PET-CT (both performed ≤60 days before surgery).
Intraoperative: During surgery, the investigator will perform, as standard in our clinical practice, an accurate exploration of the liver by inspection, palpation and IOUS. The investigator will record the identification of any liver lesion. If one or more nodules suspect of being neuroendocrine liver metastases are identified, it will be necessary, whenever possible, as already routinely performed, to carry out a biopsy or to remove it (if superficial) for histological confirmation of the diagnosis. After completion of liver staging, the primary tumor will be resected.
Postoperative / follow-up: Enrolled patients will have standard postoperative management.
Standard statistical analyses will be performed. Per-patient and per-lesion analyses will be performed to asses performances of preoperative imaging modalities (CT, MRI, PET-CT) and of intraoperative ones (inspection, palpation, and IOUS).
- Conditions
- Neuroendocrine (NE) Tumors, Liver Metastasis
- Keywords
- neuroendocrine tumors, liver metastases, intraoperative hepatic ultrasonography
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver metastases
Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging
Measured: 2020-2023
Secondary outcomes (2)
Impact on therapeutic strategies
Measured: 2020-2023
Comparison with radiological preoperative evaluation
Performances of preoperative imaging (CT, MRI and PET-CT) in comparison with those of IOUS
Measured: 2020-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Oct 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779708
- Sponsor's protocol ID
- 748/2020
- Acronym
- ECHO-NET
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vigano L, Ferrero A, Amisano M, Russolillo N, Capussotti L. Comparison of laparoscopic and open intraoperative ultrasonography for staging liver tumours. Br J Surg. 2013 Mar;100(4):535-42. doi: 10.1002/bjs.9025. Epub 2013 Jan 21.
PubMed 23339035Langella S, Ardito F, Russolillo N, Panettieri E, Perotti S, Mele C, Giuliante F, Ferrero A. Intraoperative Ultrasound Staging for Colorectal Liver Metastases in the Era of Liver-Specific Magnetic Resonance Imaging: Is It Still Worthwhile? J Oncol. 2019 Sep 22;2019:1369274. doi: 10.1155/2019/1369274. eCollection 2019.
PubMed 31662749Torzilli G, Botea F, Donadon M, Cimino M, Procopio F, Pedicini V, Poretti D, Montorsi M. Criteria for the selective use of contrast-enhanced intra-operative ultrasound during surgery for colorectal liver metastases. HPB (Oxford). 2014 Nov;16(11):994-1001. doi: 10.1111/hpb.12272. Epub 2014 May 15.
PubMed 24830573van Vledder MG, Pawlik TM, Munireddy S, Hamper U, de Jong MC, Choti MA. Factors determining the sensitivity of intraoperative ultrasonography in detecting colorectal liver metastases in the modern era. Ann Surg Oncol. 2010 Oct;17(10):2756-63. doi: 10.1245/s10434-010-1108-y. Epub 2010 Jun 2.
PubMed 20517682Elias D, Lefevre JH, Duvillard P, Goere D, Dromain C, Dumont F, Baudin E. Hepatic metastases from neuroendocrine tumors with a "thin slice" pathological examination: they are many more than you think.. Ann Surg. 2010 Feb;251(2):307-10. doi: 10.1097/SLA.0b013e3181bdf8cf.
PubMed 20010089Ruzzenente A, Bagante F, Bertuzzo F, Aldrighetti L, Campagnaro T, Ercolani G, Conci S, Giuliante F, Dore A, Ferrero A, Torzilli G, Grazi GL, Ratti F, Cucchetti A, De Rose AM, Russolillo N, Cimino M, Perri P, Guglielmi A, Iacono C. Liver Resection for Neuroendocrine Tumor Liver Metastases Within Milan Criteria for Liver Transplantation. J Gastrointest Surg. 2019 Jan;23(1):93-100. doi: 10.1007/s11605-018-3973-9. Epub 2018 Sep 21.
PubMed 30242647O'Toole D, Kianmanesh R, Caplin M. ENETS 2016 Consensus Guidelines for the Management of Patients with Digestive Neuroendocrine Tumors: An Update. Neuroendocrinology. 2016;103(2):117-8. doi: 10.1159/000443169. Epub 2016 Jan 6. No abstract available.
PubMed 26731186Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 13.
PubMed 25312765Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
PubMed 24384494Vigano L, Maruccio M, Faustini F, Frigerio I, Gavazzi F, De Robertis Lombardi R, Scopelliti F, Capretti G, Ammirabile A, D'Onofrio M, Giardino A, Ferrillo G, Rodari M, Regi P, Procopio F, Salvia R, Lania A, Butturini G, Landoni L, Torzilli G, Zerbi A. Intraoperative hepatic ultrasonography in patients with gastrointestinal and pancreatic neuroendocrine neoplasms without preoperative evidence of liver metastases. J Neuroendocrinol. 2025 Nov;37(11):e70079. doi: 10.1111/jne.70079. Epub 2025 Aug 18.
PubMed 40825538
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHO-NET Study: Role of Intraoperative Hepatic Ultrasonography in Patients with Gastrointestinal or Pancreatic Neuroendocrine Tumor Without Liver Metastases At Preoperative Imaging
- ClinicalTrials.gov ID
- NCT06779708
- Acronym / sponsor ID
- ECHO-NET / 748/2020
- Conditions
- Neuroendocrine (NE) Tumors, Liver Metastasis
- Keywords
- neuroendocrine tumors, liver metastases, intraoperative hepatic ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Jan 2025 (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.
Background: Liver metastases are common in patients with neuroendocrine neoplasms, but often underestimated by preoperative imaging. Intraoperative ultrasound (IOUS) is the reference standard for staging of primary and metastatic liver tumors, with a diagnostic accuracy superior to that of CT and MRI. Rationale: The present study aims to evaluate the contribution of IOUS to staging of liver disease in patients with neuroendocrine tumor candidates for primary tumor resection classified as cM0 at preoperative imaging.
The study will collect a prospective series of 99 patients undegoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023. All patients had to be cM0 tumor at preoperative imaging. Additional inclusion criteria: age>18 years, ability to give the informed consent for study participation; no other malignancies in the previous 5 years; preoperative staging including abdominal CT and DOTATOC PET-CT performed ≤60 days before surgery.
This prospective observational multicentre study aims to elucidate the proportion of patients with gastro-intestinal or pancreatic neuroendocrine tumor cM0 at preoperative imaging that have intraoperative detection of liver metastases at IOUS.
Primary endpoint:
- Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging
Secondary endpoints:
- Impact of IOUS on the therapeutic strategy
- Performances of preoperative imaging (CT, MRI and PET-CT) in comparison with those of IOUS
The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023.
The study includes the following steps:
Preoperative / enrollment: All patients candidates to resection of gastro-intestinal or pancreatic neuroendocrine tumor will be considered for the study. Only cM0 patients will be enrolled. All patients enrolled in the study must have performed a preoperative abdominal CT scan with contrast medium and a DOTATOC-PET-CT (both performed ≤60 days before surgery).
Intraoperative: During surgery, the investigator will perform, as standard in our clinical practice, an accurate exploration of the liver by inspection, palpation and IOUS. The investigator will record the identification of any liver lesion. If one or more nodules suspect of being neuroendocrine liver metastases are identified, it will be necessary, whenever possible, as already routinely performed, to carry out a biopsy or to remove it (if superficial) for histological confirmation of the diagnosis. After completion of liver staging, the primary tumor will be resected.
Postoperative / follow-up: Enrolled patients will have standard postoperative management.
Standard statistical analyses will be performed. Per-patient and per-lesion analyses will be performed to asses performances of preoperative imaging modalities (CT, MRI, PET-CT) and of intraoperative ones (inspection, palpation, and IOUS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres (see the Appendix for list of the centres) in the period 2020-2023.
Key inclusion criteria (5 listed)
- Patients undergoing open or minimally-invasive surgery for primary neuroendocrine gastro-intestinal or pancreatic tumor.
- cM0 tumor at preoperative imaging
- Preoperative staging including abdominal CT and DOTATOC PET-CT
- Age ≥18 years
- No other malignancies in the previous 5 years
Key exclusion criteria (3 listed)
- Preoperative imaging performed >60 days before surgery
- Patient refusal to participate the study
- Incomplete intraoperative hepatic staging (peri-hepatic adhesions, IOUs not available…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver metastases
Time frame: 2020-2023
Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging
2 secondary outcomes
Impact on therapeutic strategies
Time frame: 2020-2023
Comparison with radiological preoperative evaluation
Time frame: 2020-2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 23339035Vigano L, Ferrero A, Amisano M, Russolillo N, Capussotti L. Comparison of laparoscopic and open intraoperative ultrasonography for staging liver tumours. Br J Surg. 2013 Mar;100(4):535-42. doi: 10.1002/bjs.9025. Epub 2013 Jan 21.
- Background: PubMed 31662749Langella S, Ardito F, Russolillo N, Panettieri E, Perotti S, Mele C, Giuliante F, Ferrero A. Intraoperative Ultrasound Staging for Colorectal Liver Metastases in the Era of Liver-Specific Magnetic Resonance Imaging: Is It Still Worthwhile? J Oncol. 2019 Sep 22;2019:1369274. doi: 10.1155/2019/1369274. eCollection 2019.
- Background: PubMed 24830573Torzilli G, Botea F, Donadon M, Cimino M, Procopio F, Pedicini V, Poretti D, Montorsi M. Criteria for the selective use of contrast-enhanced intra-operative ultrasound during surgery for colorectal liver metastases. HPB (Oxford). 2014 Nov;16(11):994-1001. doi: 10.1111/hpb.12272. Epub 2014 May 15.
- Background: PubMed 20517682van Vledder MG, Pawlik TM, Munireddy S, Hamper U, de Jong MC, Choti MA. Factors determining the sensitivity of intraoperative ultrasonography in detecting colorectal liver metastases in the modern era. Ann Surg Oncol. 2010 Oct;17(10):2756-63. doi: 10.1245/s10434-010-1108-y. Epub 2010 Jun 2.
- Background: PubMed 20010089Elias D, Lefevre JH, Duvillard P, Goere D, Dromain C, Dumont F, Baudin E. Hepatic metastases from neuroendocrine tumors with a "thin slice" pathological examination: they are many more than you think.. Ann Surg. 2010 Feb;251(2):307-10. doi: 10.1097/SLA.0b013e3181bdf8cf.
- Background: PubMed 30242647Ruzzenente A, Bagante F, Bertuzzo F, Aldrighetti L, Campagnaro T, Ercolani G, Conci S, Giuliante F, Dore A, Ferrero A, Torzilli G, Grazi GL, Ratti F, Cucchetti A, De Rose AM, Russolillo N, Cimino M, Perri P, Guglielmi A, Iacono C. Liver Resection for Neuroendocrine Tumor Liver Metastases Within Milan Criteria for Liver Transplantation. J Gastrointest Surg. 2019 Jan;23(1):93-100. doi: 10.1007/s11605-018-3973-9. Epub 2018 Sep 21.
- Background: PubMed 26731186O'Toole D, Kianmanesh R, Caplin M. ENETS 2016 Consensus Guidelines for the Management of Patients with Digestive Neuroendocrine Tumors: An Update. Neuroendocrinology. 2016;103(2):117-8. doi: 10.1159/000443169. Epub 2016 Jan 6. No abstract available.
- Background: PubMed 25312765Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 13.
- Background: PubMed 24384494Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
- Derived from this study: PubMed 40825538Vigano L, Maruccio M, Faustini F, Frigerio I, Gavazzi F, De Robertis Lombardi R, Scopelliti F, Capretti G, Ammirabile A, D'Onofrio M, Giardino A, Ferrillo G, Rodari M, Regi P, Procopio F, Salvia R, Lania A, Butturini G, Landoni L, Torzilli G, Zerbi A. Intraoperative hepatic ultrasonography in patients with gastrointestinal and pancreatic neuroendocrine neoplasms without preoperative evidence of liver metastases. J Neuroendocrinol. 2025 Nov;37(11):e70079. doi: 10.1111/jne.70079. Epub 2025 Aug 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine (NE) Tumors and Liver Metastasis, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jan 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver metastases (time frame: 2020-2023). 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 NCT06779708, which also lists 10 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 16 Jan 2025.