Clinical trial · Interventional
Biopsy Technique for Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer
Single-bite Versus Double-bite Technique for Mapping Biopsies During Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer: a Single Center, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Diffuse Gastric Cancer | Hereditary Gastric Diffuse Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double bite biopsy technique | Other | — | UNRESOLVED |
| Single bite biopsy technique | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Single bite
- description
- The single bite technique involved removing the forceps with its specimen after each individual biopsy.
- interventionNames
- Other: Single bite biopsy technique
- type
- OTHER
- label
- Double bite
- description
- 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.
- interventionNames
- Other: Double bite biopsy technique
Primary outcomes (1)
- measure
- Identification of signet ring cell carcinoma (SRCC) foci.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDvan 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. PMID 25979631
- BACKGROUNDMi EZ, Mi EZ, di Pietro M, O'Donovan M, Hardwick RH, Richardson S, Ziauddeen H, Fletcher PC, Caldas C, Tischkowitz M, Ragunath K, Fitzgerald RC. Comparative study of endoscopic surveillance in hereditary diffuse gastric cancer according to CDH1 mutation status. Gastrointest Endosc. 2018 Feb;87(2):408-418. doi: 10.1016/j.gie.2017.06.028. Epub 2017 Jul 6. PMID 28688938
- BACKGROUNDFewings E, Larionov A, Redman J, Goldgraben MA, Scarth J, Richardson S, Brewer C, Davidson R, Ellis I, Evans DG, Halliday D, Izatt L, Marks P, McConnell V, Verbist L, Mayes R, Clark GR, Hadfield J, Chin SF, Teixeira MR, Giger OT, Hardwick R, di Pietro M, O'Donovan M, Pharoah P, Caldas C, Fitzgerald RC, Tischkowitz M. Germline pathogenic variants in PALB2 and other cancer-predisposing genes in families with hereditary diffuse gastric cancer without CDH1 mutation: a whole-exome sequencing study. Lancet Gastroenterol Hepatol. 2018 Jul;3(7):489-498. doi: 10.1016/S2468-1253(18)30079-7. Epub 2018 Apr 27. PMID 29706558
- DERIVEDPappas A, Tan WK, Waldock W, Richardson S, Tripathi M, Januszewicz W, Roberts G, O'Donovan M, Fitzgerald RC, di Pietro M. Single-bite versus double-bite technique for mapping biopsies during endoscopic surveillance for hereditary diffuse gastric cancer: a single-center, randomized trial. Endoscopy. 2021 Mar;53(3):246-253. doi: 10.1055/a-1201-3125. Epub 2020 Jul 17. PMID 32679601