Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biopsy Technique for Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950908
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Massimiliano di Pietro, MD, University of Cambridge

Brief Summary:
Germline mutation in e-cadherin gene (CDH1) is found in approximately 25% to 30% of individuals fulfilling the clinical criteria for hereditary diffuse gastric cancer (HDGC). Prophylactic gastrectomy is the mainstay of the management of cases with pathogenetic CDH1 mutation. However, some individuals refuse gastrectomy and prefer to delay it for medical or psychosocial reasons. For these patients as well as for those in which a pathogenetic mutation is not found, endoscopic surveillance is recommended. The suggested endoscopic protocol involves targeted as well as 30 random biopsies, which is tedious and time-consuming . In order to save time, two specimens can be taken during a single passage of the biopsy forceps ("double-bite" technique). The aim of this study was to determine the adequacy and utility of the "double-bite" technique in patients undergoing surveillance for HDGC as compared to the standard "single-bite technique".

Condition or disease Intervention/treatment Phase
Hereditary Diffuse Gastric Cancer Other: Single bite biopsy technique Other: Double bite biopsy technique Not Applicable

Detailed Description:

Previous studies have validated endoscopy, as an efficient tool for initial screening and in selected cases surveillance of families fulfilling the clinical criteria for hereditary diffuse gastric cancer (HDGC). The aim is to detect microscopic foci of in situ or intramucosal signet ring cell carcinoma (SRCC), which are characteristic of early HDGC. Currently, the recommended endoscopic protocol involves targeted biopsies of any suspicious lesion as well as a minimum of 30 mapping random biopsies specimens taken from all anatomic areas of the gastric mucosa, also known as Cambridge endoscopy protocol. However this is a time-consuming and tedious process, which significantly prolongs the duration of the procedure and might reduce patient tolerance. In order to save time two specimens can be taken during a single passage of the forceps ("double-bite" technique).

In order to evaluate the adequacy and utility of the "double-bite" technique, patients undergoing surveillance for HDGC, are randomized to the single-bite vs double-bite arm. Endoscopies are performed according to a standardized protocol. Briefly, a white-light high-resolution endoscope with 85 magnification and a maximal resolution of 7.9 mm (GIF-FQ260Z; Olympus, Tokyo, Japan) is used to examine all anatomic segments of the insufflated stomach. Any abnormalities on white-light endoscopy are recorded and assessed further by narrow-band imaging magnification with or without autofluorescence imaging. Targeted biopsy specimens are taken from identified lesions, and 5 random biopsy specimens are taken in each of the siz gastric anatomical areas (prepylorus, antrum, transitional zone, body, fundus, and cardia). The double-bite technique involves taking an initial biopsy, repositioning the forceps, and taking another biopsy from the same area with the initial specimen still on the forceps. The single bite technique involves removing the forceps with its specimen after each individual biopsy. Time is recorded between the first and last random biopsy. Comfort score is reported after the procedure, according to the modified Gloucester scale. The investigators use Boston Single-Use Radial Jaw™ 4 biopsy forceps with a spike. Biopsy specimens are stained with hematoxylin and eosin and periodic acid-Schiff diastase and are assessed for size and presence of SRCC foci by an upper specialist GI pathologist, who have significant experience in SRCC identification. Any lesions are checked by a second pathologist within the Cambridge Pathology team before reporting. Both pathologists are blinded to study arm.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Single-bite Versus Double-bite Technique for Mapping Biopsies During Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer: a Single Center, Randomized Controlled Trial
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018


Arm Intervention/treatment
Single bite
The single bite technique involved removing the forceps with its specimen after each individual biopsy.
Other: Single bite biopsy technique
During biopsy collection one specimen will be retrieved during a single passage of the biopsy forceps.

Double bite
The double-bite technique involved taking an initial biopsy, repositioning the forceps, and taking another biopsy from the same area with the initial specimen still on the forceps.
Other: Double bite biopsy technique
During biopsy collection two specimens will be retrieved during a single passage of the biopsy forceps.




Primary Outcome Measures :
  1. Identification of signet ring cell carcinoma (SRCC) foci. [ Time Frame: 1 year ]
    Evaluating the diagnostic yield of the double-bite technique, by means of identifying SRCC foci, in comparison to the conventional single -bite arm.


Secondary Outcome Measures :
  1. Time to perform biopsy protocol. [ Time Frame: 1 year ]
    Differences between the study arms in terms of time required for biopsy collection

  2. Biopsy size [ Time Frame: 1 year ]
    Differences between the study arms in terms of size of the biopsy specimens

  3. Patients comfort [ Time Frame: 1 year ]

    Differences between the study arms in terms of patient comfort score, during the procedure. Comfort score is reported after the procedure, according to the modified Gloucester scale.

    1: No discomfort - resting comfortably throughout; 2: Minimal. One or two episodes of mild discomfort, well tolerated; 3:Mild. More than 2 episodes of discomfort, adequately tolerated; 4: Moderate. Significant discomfort experienced several times during the procedure; 5: Severe. Extreme discomfort, experienced frequently during the procedure


  4. Dose of sedation. [ Time Frame: 1 year ]
    Differences between the study arms in terms of dose required for sedation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion criteria:

  • Patients in the Familial Gastric Cancer Registry held in Cambridge fulfilling clinical criteria for HDGC.
  • Patients willing to undergo at least one upper GI endoscopy with random biopsies according to Cambridge biopsy protocol.

Exclusion criteria:

  • Patients who decline evaluation with endoscopy either as a screening or surveillance tool
  • Patients on clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.

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): NCT03950908


Locations
Layout table for location information
United Kingdom
MRC Cancer Unit
Cambridge, United Kingdom
Sponsors and Collaborators
University of Cambridge
Investigators
Layout table for investigator information
Principal Investigator: Massimiliano di Pietro, MD MRC Cancer Unit.University of Cambridge.

Publications:
van der Post RS, Vogelaar IP, Carneiro F, Guilford P, Huntsman D, Hoogerbrugge N, Caldas C, Schreiber KE, Hardwick RH, Ausems MG, Bardram L, Benusiglio PR, Bisseling TM, Blair V, Bleiker E, Boussioutas A, Cats A, Coit D, DeGregorio L, Figueiredo J, Ford JM, Heijkoop E, Hermens R, Humar B, Kaurah P, Keller G, Lai J, Ligtenberg MJ, O'Donovan M, Oliveira C, Pinheiro H, Ragunath K, Rasenberg E, Richardson S, Roviello F, Schackert H, Seruca R, Taylor A, Ter Huurne A, Tischkowitz M, Joe ST, van Dijck B, van Grieken NC, van Hillegersberg R, van Sandick JW, Vehof R, van Krieken JH, Fitzgerald RC. Hereditary diffuse gastric cancer: updated clinical guidelines with an emphasis on germline CDH1 mutation carriers. J Med Genet. 2015 Jun;52(6):361-74. doi: 10.1136/jmedgenet-2015-103094. Epub 2015 May 15. Review.

Layout table for additonal information
Responsible Party: Massimiliano di Pietro, MD, Senior Clinician Scientist. Consultant Gastroenterologist., University of Cambridge
ClinicalTrials.gov Identifier: NCT03950908     History of Changes
Other Study ID Numbers: FGCS protocol v.10
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases