- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00548626
Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer (EMUNE-07)
EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer
연구 개요
상세 설명
This is a prospective randomized controlled trial which will recruit patients referred for suspicion of pancreatic mass and indication of EUS-FNA as part of standard of care in the Interventional Endoscopy Unit at the University Of Chicago Medical Center. Basic demographic data will be recorded for each patient. If a pancreatic mass is confirmed in EUS evaluation the patient will be randomized in a 1:1 ratio to either Control group (Single needle) or Investigational group (Multiple Needle). There will be an expert cytopathologist in the exploration room (blinded to the group assignment). Samples obtained through FNA will be prepared onsite either for cytological evaluation by the cytopathologist: each fine needle sample will be expressed by using a 10mL air-filled syringe onto a separate glass slide, and a direct smear will be made by an on-site cytopathologist. Each slide will be air-dried and/or alcohol fixed (95% ethanol), and direct smears will be prepared for immediate interpretation by staining with Diff-quick staining system.
Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
A cytopathologist (#1) will be present during each EUS-FNA procedure to prepare the slides and determine whether each specimen was adequately cellular. After the procedure, all the cytological samples will be sent to the Pathology department in order to complete the study. A cytopathologist (#2) not present during the procedure will study all the sampling specimens obtained during the EUS-FNA procedure and produce the final and definitive cytopathological diagnosis.
Criteria for pancreatic cancer and benign pancreatic lesions will be defined. Follow-up of all patients to assess early and late complications will be carried out for 30 days after the procedure.
Endpoints:
- Primary endpoint: Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia. We hypothesized that the number of passes needed using the multiple needles will be significantly less than that using the single needle.
Secondary endpoints:
- Rate of complications related with EUS-FNA
- Influence of different factors in obtaining a positive cytological result (histological differentiation)
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- University Of Chicago Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Suspicion of pancreatic mass due to previous exam/s (CT, MR, ERCP, US, …) that requires EUS-FNA in order to complete diagnosis
- Age ≥ 18 y/o
- Formal informed consent
- No previous chemotherapy or radiotherapy
- No previous pancreatic surgery
Exclusion Criteria:
- Any patient unable to understand the procedure, nature of the current study, or sign a consent form.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: A
Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance).
After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
|
Patients will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance).
After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
|
실험적: B
Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes.
After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
|
Patients will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes.
After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia.
기간: October 2007- September 2008
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October 2007- September 2008
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2차 결과 측정
결과 측정 |
기간 |
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Rate of complications related with EUS-FNA
기간: October 2007- September 2008
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October 2007- September 2008
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Influence of different factors in obtaining a positive cytological result
기간: October 2007- September 2008
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October 2007- September 2008
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공동 작업자 및 조사자
수사관
- 수석 연구원: Irving Waxman, MD, Department of Medicine, University of Chicago Medical Center
간행물 및 유용한 링크
일반 간행물
- Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7. doi: 10.1067/mge.2001.117764.
- LeBlanc JK, Ciaccia D, Al-Assi MT, McGrath K, Imperiale T, Tao LC, Vallery S, DeWitt J, Sherman S, Collins E. Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis. Gastrointest Endosc. 2004 Apr;59(4):475-81. doi: 10.1016/s0016-5107(03)02863-3.
- Eloubeidi MA, Tamhane A, Varadarajulu S, Wilcox CM. Frequency of major complications after EUS-guided FNA of solid pancreatic masses: a prospective evaluation. Gastrointest Endosc. 2006 Apr;63(4):622-9. doi: 10.1016/j.gie.2005.05.024.
- Eloubeidi MA, Gress FG, Savides TJ, Wiersema MJ, Kochman ML, Ahmad NA, Ginsberg GG, Erickson RA, Dewitt J, Van Dam J, Nickl NJ, Levy MJ, Clain JE, Chak A, Sivak MV Jr, Wong R, Isenberg G, Scheiman JM, Bounds B, Kimmey MB, Saunders MD, Chang KJ, Sharma A, Nguyen P, Lee JG, Edmundowicz SA, Early D, Azar R, Etemad B, Chen YK, Waxman I, Shami V, Catalano MF, Wilcox CM. Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States. Gastrointest Endosc. 2004 Sep;60(3):385-9. doi: 10.1016/s0016-5107(04)01714-6.
- Harewood GC, Wiersema MJ. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol. 2002 Jun;97(6):1386-91. doi: 10.1111/j.1572-0241.2002.05777.x.
- Eloubeidi MA, Jhala D, Chhieng DC, Chen VK, Eltoum I, Vickers S, Mel Wilcox C, Jhala N. Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer. 2003 Oct 25;99(5):285-92. doi: 10.1002/cncr.11643.
- O'Toole D, Palazzo L, Arotcarena R, Dancour A, Aubert A, Hammel P, Amaris J, Ruszniewski P. Assessment of complications of EUS-guided fine-needle aspiration. Gastrointest Endosc. 2001 Apr;53(4):470-4. doi: 10.1067/mge.2001.112839.
- Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
- Niederhuber JE, Brennan MF, Menck HR. The National Cancer Data Base report on pancreatic cancer. Cancer. 1995 Nov 1;76(9):1671-7. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-r.
- Binmoeller KF, Thul R, Rathod V, Henke P, Brand B, Jabusch HC, Soehendra N. Endoscopic ultrasound-guided, 18-gauge, fine needle aspiration biopsy of the pancreas using a 2.8 mm channel convex array echoendoscope. Gastrointest Endosc. 1998 Feb;47(2):121-7. doi: 10.1016/s0016-5107(98)70343-8.
- Mortensen MB, Pless T, Durup J, Ainsworth AP, Plagborg GJ, Hovendal C. Clinical impact of endoscopic ultrasound-guided fine needle aspiration biopsy in patients with upper gastrointestinal tract malignancies. A prospective study. Endoscopy. 2001 Jun;33(6):478-83. doi: 10.1055/s-2001-14966.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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