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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03264092
• Other study ID #: E17118
• Status: Terminated
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2021
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Texas Tech university Health Sciences Center El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Contamination Score of Each Specimen Obtained	This is based on the following scale; Blood present; Blood clots present	2 hours
Secondary	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