The Role of Intraoperative Hepatic Ultrasonography in Gastrointestinal or Pancreatic Neuroendocrine Tumor

NCT06779708 | Completed

• 1 other identifier: 748/2020
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Neuroendocrine (NE) Tumors; Liver Metastasis

Keywords

neuroendocrine tumors; liver metastases; intraoperative hepatic ultrasonography

Outcome Measures

Primary Outcomes (1)

• Liver metastases

  Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging

  2020-2023

Secondary Outcomes (2)

• Impact on therapeutic strategies

  2020-2023

• Comparison with radiological preoperative evaluation

  2020-2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Preoperative imaging performed \>60 days before surgery
• Patient refusal to participate the study
• Incomplete intraoperative hepatic staging (peri-hepatic adhesions, IOUs not available…)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

Related Publications (9)

• 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.

  PMID: 23339035 BACKGROUND

• Langella 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.

  PMID: 31662749 BACKGROUND

• Torzilli 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.

  PMID: 24830573 BACKGROUND

• van 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.

  PMID: 20517682 BACKGROUND

• Elias 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.

  PMID: 20010089 BACKGROUND

• Ruzzenente 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.

  PMID: 30242647 BACKGROUND

• O'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.

  PMID: 26731186 BACKGROUND

• Hallet 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.

  PMID: 25312765 BACKGROUND

• Frilling 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.

  PMID: 24384494 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 16, 2025
• Study Start: October 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)