Feasibility and Yield of a New 20 G ProCore Needle With Coiled Sheath in the Gastrointestinal Subepithelial Tumors

NCT02884154 | Completed

• 1 other identifier: K_EUS_Study_1
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The exact incidence of subepithelial tumors (SETs) in the gastrointestinal (GI) tract is unknown, but the prevalence of gastric SETs detected during routine esophagogastroduodenoscopy is 0.36%. GI SETs may include leiomyoma, GI stromal tumor (GIST), schwannoma, lipoma, cyst, or ectopic pancreas. Surgical resection is the principal diagnostic and therapeutic method for SETs, especially for large and symptomatic ones. Preoperative pathological diagnosis of SETs may facilitate clinical decision making, but conventional endoscopic forceps biopsy does not yield adequate amounts of subepithelial tissue for definitive diagnosis. Although endoscopic ultrasonography (EUS) is the best imaging modality for the evaluation of SETs, it cannot substitute histopathological diagnosis. EUS-guided fine-needle aspiration (EUS-FNA) may provide adequate amounts of tissue for the diagnosis of SETs, but it does not always afford adequate samples for immunohistochemical analysis because of the often small number of cells obtained by aspiration. Since some SETs, especially GI mesenchymal tumors such as GIST or schwannoma, have varied morphologic appearances, and diagnosis using a small biopsy is not straightforward, immunohistochemical analysis is strongly advisable, if not essential. EUS-guided Trucut biopsy (EUS-TNB) may overcome the limitations of EUS-FNA in procuring sufficient core tissue specimens. Although EUS-TNB is more accurate than EUS-FNA for diagnosing GI mesenchymal tumors, the rigidity of its 19-gauge (G) caliber and the mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its use for SETs located in the gastric antrum and duodenum. Therefore, a needle facilitating adequate histological core sampling with easy maneuverability needs to be established. A 19G EUS-guided fine-needle biopsy (EUS-FNB) device with ProCore reverse-bevel technology was recently introduced. A multicenter study revealed that histological samples could be successfully obtained using this needle in most patients having GI SETs, with a diagnostic accuracy of \>80%.10 However, because of technical difficulties with this needle in the gastric antrum and duodenum, the same FNB device was recently developed in a 20 G platform with coiled sheath. This prospective, multicenter study aimed to evaluate feasibility, yield, and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath in patients with GI SETs.

Conditions

Gastrointestinal Tract; Gastrointestinal Stromal Tumor

Keywords

Endoscopic ultrasonography; Biopsy; Gastrointestinal tract; Subepithelial tumor

Outcome Measures

Primary Outcomes (1)

• diagnostic sufficiency

  Diagnostic sufficiency is defined as the proportion of patients in whom the histopathological diagnosis could be established within three needle passes.

  up to 2 weeks

Secondary Outcomes (3)

• diagnostic failure rate

  up to 2 weeks

• technical failure rate

  up to 1 day

• complications

  up to 4 weeks

Study Arms (1)

Arm who will undergo EUS-FNB

OTHER

Device: Echotip ProCoreⓇ HD Ultrasound Biopsy Needle

Interventions

Echotip ProCoreⓇ HD Ultrasound Biopsy Needle DEVICE

Arm who will undergo EUS-FNB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a hypoechoic mass in the submucosal and/or proper muscle layers on the basis of EUS and tumor \>2 cm in size

You may not qualify if:

• SETs were not located in the submucosal and/or proper muscle layers on EUS
• EUS revealed the characteristic findings of lipoma, cyst, vessel or extraluminal lesions; the platelet count was \<50,000/mm3 and prothrombin time was \<50%
• The patient did not provide consent to undergo the study

Sponsors & Collaborators

• Pusan National University Hospital: lead

Related Publications (1)

• Kim DH, Kim GH, Cho CM, Park CH, Na SY, Kim TH, Cho YK, Kim JH, Seo DW; Korean EUS Study Group. Feasibility of a 20-gauge ProCore needle in EUS-guided subepithelial tumor sampling: a prospective multicenter study. BMC Gastroenterol. 2018 Oct 19;18(1):151. doi: 10.1186/s12876-018-0880-1.

  PMID: 30340469 DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01