Trial Outcomes & Findings for EUS-CNB Versus EUS-SINK for Diagnosis of Upper Gastrointestinal (UGI) Subepithelial Tumors (NCT NCT02282111)

NCT ID: NCT02282111

Last Updated: 2018-10-09

Results Overview

Diagnostic accuracy is defined as the percentage of true positive and true negative biopsy specimens combined divided by total number of specimens

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-10-09

Participant Flow

Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at Endoscopic Ultrasound scan (EUS).

Participant milestones

Measure	EUS-CNB Endoscopic ultrasound-core needle biopsy technique 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle was used to take a biopsy from the subepithelial lesion	EUS-SINK Endoscopic ultrasound- single incision needle knife technique Conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome was used to take a biopsy of the subepithelial lesion
Overall Study STARTED	26	30
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	EUS-CNB n=26 Participants Endoscopic ultrasound-core needle biopsy technique 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle will be used to take a biopsy from the subepithelial lesion	EUS-SINK n=30 Participants Endoscopic ultrasound- single incision needle knife technique conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome will be used to take a biopsy of the subepithelial lesion	Total n=56 Participants Total of all reporting groups
Age, Continuous	68.7 years STANDARD_DEVIATION 11.9 • n=26 Participants	66.2 years STANDARD_DEVIATION 13.4 • n=30 Participants	67.4 years STANDARD_DEVIATION 12.7 • n=56 Participants
Sex: Female, Male Female	11 Participants n=26 Participants	14 Participants n=30 Participants	25 Participants n=56 Participants
Sex: Female, Male Male	15 Participants n=26 Participants	16 Participants n=30 Participants	31 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Layer of origin Submucosa	7 participants n=26 Participants	9 participants n=30 Participants	16 participants n=56 Participants
Layer of origin Muscularis propria	17 participants n=26 Participants	17 participants n=30 Participants	34 participants n=56 Participants
Layer of origin Indeterminate	2 participants n=26 Participants	4 participants n=30 Participants	6 participants n=56 Participants
Echogenicity Hypoechoic	19 participants n=26 Participants	22 participants n=30 Participants	41 participants n=56 Participants
Echogenicity Isoechoic	5 participants n=26 Participants	7 participants n=30 Participants	12 participants n=56 Participants
Echogenicity Hyperechoic	1 participants n=26 Participants	1 participants n=30 Participants	2 participants n=56 Participants
Echogenicity Mixed echogenicity	1 participants n=26 Participants	0 participants n=30 Participants	1 participants n=56 Participants
Location of the lesion Esophagus	1 participants n=26 Participants	1 participants n=30 Participants	2 participants n=56 Participants
Location of the lesion Gastric fundus	7 participants n=26 Participants	9 participants n=30 Participants	16 participants n=56 Participants
Location of the lesion Gastric body	12 participants n=26 Participants	12 participants n=30 Participants	24 participants n=56 Participants
Location of the lesion Antrum	4 participants n=26 Participants	7 participants n=30 Participants	11 participants n=56 Participants
Location of the lesion Doudenum	2 participants n=26 Participants	1 participants n=30 Participants	3 participants n=56 Participants
Calcification Yes	0 participants n=26 Participants	4 participants n=30 Participants	4 participants n=56 Participants
Calcification No	26 participants n=26 Participants	26 participants n=30 Participants	52 participants n=56 Participants
Greatest diameter of the lesion	23.5 millimeters n=26 Participants	25 millimeters n=30 Participants	24.5 millimeters n=56 Participants

PRIMARY outcome

Timeframe: 30 days

Diagnostic accuracy is defined as the percentage of true positive and true negative biopsy specimens combined divided by total number of specimens

Outcome measures

Measure	EUS-CNB n=19 Participants Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.	SINK n=22 Participants Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Diagnostic Accuracy	94.7 percentage of all samples Interval 74.2 to 99.0	95.5 percentage of all samples Interval 77.3 to 99.2

SECONDARY outcome

Timeframe: 30 days

This will be assessed by the percentage of patients whose samples were adequate for histopathological evaluation

Outcome measures

Measure	EUS-CNB n=26 Participants Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.	SINK n=30 Participants Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Histological Yield	76.9 percentage of participants Interval 57.9 to 88.9	86.6 percentage of participants Interval 70.3 to 94.6

SECONDARY outcome

Timeframe: 1 day

Percentage of procedures in whom sampling technique failed to take biopsy specimens

Outcome measures

Measure	EUS-CNB n=26 Participants Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.	SINK n=30 Participants Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Technical Failure Rate	3.3 percentage of procedures Interval 0.5 to 16.6	3.8 percentage of procedures Interval 0.6 to 18.8

SECONDARY outcome

Timeframe: Tissue sampling procedure, up to 60 minutes

Time from the beginning of the incision or needle insertion, to completion of tissue acquisition by the techniques defined in the protocol.

Outcome measures

Measure	EUS-CNB n=26 Participants Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.	SINK n=30 Participants Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Time of the Procedure	12 minutes Interval 8.0 to 20.0	11 minutes Interval 8.0 to 17.0

SECONDARY outcome

Timeframe: 30 days

Percentage of all samples from participants in whom biopsy specimen was adequate enough to contribute to immunohistochemistry diagnosis

Outcome measures

Measure	EUS-CNB n=19 Participants Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.	SINK n=22 Participants Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Percent Sample Contribution to Immunohistochemistry Diagnosis	94.7 percentage of all samples Interval 75.3 to 99.0	86.4 percentage of all samples Interval 66.6 to 95.2

Adverse Events

EUS-CNB

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SINK

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EUS-CNB n=26 participants at risk Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated.	SINK n=30 participants at risk Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
Surgical and medical procedures Delayed bleeding	7.7% 2/26 • Number of events 2 • Adverse events were evaluated from the start of the procedure up to 1 week after the procedure.	6.7% 2/30 • Number of events 2 • Adverse events were evaluated from the start of the procedure up to 1 week after the procedure.
Gastrointestinal disorders Abdominal pain	0.00% 0/26 • Adverse events were evaluated from the start of the procedure up to 1 week after the procedure.	3.3% 1/30 • Number of events 1 • Adverse events were evaluated from the start of the procedure up to 1 week after the procedure.

Additional Information

Dr. Mouen A. Khashab

The Johns Hopkins Hospital

Phone: 410-502-0064

Email: mkhasha1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place