Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.

Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.

The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor
• Intervention / Treatment: Procedure: Endoscopic ultrasound guided fine needle biopsy

Detailed Description

Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS).

wall cells.

In the "suction technique" the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle.

The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle.

In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages between 18-80 years old
2. Sex: male or female
3. Patients who require EUS and tissue sampling of solid solid lesions (size >1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney.
4. Patients who are able to give consent

Exclusion Criteria:

1. Pregnant female
2. Coagulation disorders (platelets < 50,000/mm3, INR > 2)
3. Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
4. Cardiorespiratory dysfunction that precludes sedation.
5. Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Wet suction; This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique	Procedure: Endoscopic ultrasound guided fine needle biopsy; Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
EXPERIMENTAL: Dry suction; This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique	Procedure: Endoscopic ultrasound guided fine needle biopsy; Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
EXPERIMENTAL: Slow pull; This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique	Procedure: Endoscopic ultrasound guided fine needle biopsy; Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score	0: inadequate; limited cytological dx; adquate cytological dx; limited histological dx; adequate histological dx with low quality; adequate histological dx with high quality	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Contamination Score of Each Specimen Obtained	This is based on the following scale; Blood present; Blood clots present	2 hours
Number of Participants Stratified Per the Number of Diagnostic Passes Required	This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.	2 hours

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Antonio Mendoza Ladd, MD, Texas Tech University Health Sciences Center, El Paso

Publications and helpful links

General Publications

• Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.
• Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
• Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2017
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: E17118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No