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Image-guided Lymphadanectomy in AMIGO

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ClinicalTrials.gov Identifier: NCT03283423
Recruitment Status : Not yet recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Siemens Corporation, Corporate Technology
KARL STORZ Endoscopy-America, Inc.
Information provided by (Responsible Party):
Ali Tavakkoli, Brigham and Women's Hospital

Brief Summary:
To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of minimizing surgical risk and improving accuracy of biopsy.

Condition or disease Intervention/treatment Phase
Lymphadenopathy Retroperitoneal Lymphoma Device: Image-guided Lymphadanectomy in AMIGO Not Applicable

Detailed Description:

Only the superficial lymph nodes are accessible to physical examination, and assessment of deeper nodes, such as those in the abdomen, requires radiological imaging. As a result, abdominal CT and PET scanning of patients with a history of malignancy or concerns for a new diagnosis of cancer is an important diagnostic test. As well as looking for distant metastasis, the images are carefully assessed for evidence of intra-abdominal lymphadenopathy, which can be a marker of new or recurrent cancer. If such nodes are identified, they often require a biopsy for further evaluation.

The lymph nodes located in the abdomen or the retroperitoneum are not easily accessible for percutaneous biopsy, often requiring an abdominal exploration which can be done either laparoscopically or via laparotomy. The laparoscopic approach represents a better approach that is associated with reduced surgical risks and complications as well as a quicker recover. In fact in many cases, the laparoscopic approach can be done as a day surgery procedure.

Although non-invasive imaging technologies such as computed tomography (CT) scanning, magnetic resonance imaging (MRI), and positron emission tomography (PET) scanning can be useful in the diagnosis of lymphadenopathy, they often provide an estimate of the location of the nodes, and exact localization of the lymph node of interest can be challenging. The surgeons rely on anatomical landmarks which can be distorted during laparoscopy and to help reduce the rate of false negative lymph node biopsy, the surgeons often perform intra-operative histological assessment of the lymph nodes (Frozen Section) which can be time consuming and in itself associated with diagnostic errors. The uncertainty about the exact location of the node of interest often leads to extensive surgical dissection, biopsy of multiple nodes, and sometimes repeat surgery. During the dissection, care must be taken to avoid injury to the neighboring structures, such as blood vessels, nerves or adjacent organs. In cases, where an intra-operative dissection occurs, or lymph nodes can not be identified, the laparoscopic surgery is converted to open surgery.

Using the unique capabilities of the AMIGO suite, investigators aim to test intra-operative image guidance to help them identify diseased intra-abdominal lymph nodes, allowing for more precise and safer surgeries. The improved accuracy will allow investigators to perform surgeries with minimal dissection and reduced complications while improving biopsy rates and enhancing ability to accurately stage intra-abdominal malignancies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image-guided Lymphadanectomy in AMIGO
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Image-guided Lymphadanectomy in AMIGO
    Image guided laparoscopic lymph node biopsy


Primary Outcome Measures :
  1. Accuracy of lymph node biopsy [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent before any trial related procedure is undertaken that is not part of the standard patient management
  • Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in the abdomen or retroperitoneum, with scheduled confirmatory surgical biopsy.
  • Subjects must have had a CT, PET examination or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month

Exclusion Criteria:

  • Severely impaired renal function with an EGFR < 30 mL/min/body surface area
  • Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
  • History of hypersensitivity or other contraindication to contrast media
  • Contraindication to general anesthesia
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283423


Contacts
Contact: Ali Tavakkoli, MD 6177326337 atavakkoli@bwh.harvard.edu
Contact: Jayender Jagadeesen, PhD 617-278-0986 jayender@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Siemens Corporation, Corporate Technology
KARL STORZ Endoscopy-America, Inc.
Investigators
Principal Investigator: Ali Tavakkoli, MD Brigham and Women's Hopistal

Responsible Party: Ali Tavakkoli, Associate Surgeon, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03283423     History of Changes
Other Study ID Numbers: 2016P002535
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Lymphadenopathy
Lymphatic Diseases