Trial Outcomes & Findings for EUS GUIDED Transduodenal Biopsy Using the 19G Flex (NCT NCT02307253)

Results Overview

Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

246 participants

Primary outcome timeframe

Intraoperative

Results posted on

2022-06-27

Participant Flow

consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study.

Participant milestones

Participant milestones
Measure	Patients With Solid Lesions Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Overall Study STARTED	246
Overall Study COMPLETED	246
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Solid Lesions n=246 Participants all consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study. Selection criteria All adults (\>18 years of age) referred for EUS-FNA of solid lesions adjacent to or located in the wall of the duodenum with no previous tissue diagnosis were considered eligible. In the presence of a cystic component, the solid part of the lesion should have been more than 75% of the total. Patients with uncorrectable coagulopathy as defined by abnormal prothrombin time or partial thromboplastin time that did not normalize after administration of fresh frozen plasma, with altered anatomy of the upper GI tract due to surgery of the esophagus, stomach, and duodenum and those unable to understand and/or read the consent form were excluded from the current study.
Age, Continuous	65.1 years STANDARD_DEVIATION 12.7 • n=246 Participants
Sex: Female, Male Female	102 Participants n=246 Participants
Sex: Female, Male Male	144 Participants n=246 Participants
Region of Enrollment United States	30 participants n=246 Participants
Region of Enrollment Japan	25 participants n=246 Participants
Region of Enrollment Italy	152 participants n=246 Participants
Region of Enrollment France	39 participants n=246 Participants

PRIMARY outcome

Timeframe: Intraoperative

Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.

Outcome measures

Outcome measures
Measure	Patients With Solid Lesions n=246 Participants Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion	228 Participants

SECONDARY outcome

Timeframe: intraoperative and within 3 days after the procedure

rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period

Outcome measures

Outcome measures
Measure	Patients With Solid Lesions n=246 Participants Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Number of Complications Divided Per Total Number of Enrolled Patients	6 Participants

SECONDARY outcome

Timeframe: 5 days

percentage of patients in whom a histologically interpretable specimen will be retrieved

Outcome measures

Outcome measures
Measure	Patients With Solid Lesions n=246 Participants Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Number of Histological Samples Judged Adequate Divided by the Total Number of Patients	189 Participants

SECONDARY outcome

Timeframe: 6 months

rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy

Outcome measures

Outcome measures
Measure	Patients With Solid Lesions n=246 Participants Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Number of Correct Diagnosis Divided by the Total Number of Patients	181 Participants

Adverse Events

Patients With Solid Lesions

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Solid Lesions n=246 participants at risk Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Gastrointestinal disorders Bleeding	0.81% 2/246 • Number of events 2 • 6 months
Hepatobiliary disorders acute pancreatitis	0.81% 2/246 • Number of events 2 • 6 months
Gastrointestinal disorders duodenal perforation	0.41% 1/246 • Number of events 1 • 6 months
Gastrointestinal disorders duodenal hematoma	0.41% 1/246 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr Alberto Larghi

Fondazione Policlino Universitario A Gemelli IRCCS

Phone: 0630156580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place