Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases

Overview

The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient. The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost. A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability. The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.

Full Title of Study: “Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial ” EASYSPY “”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 28, 2019

Interventions

  • Procedure: cholangio-pancreatoscopy

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.
    • Time Frame: 4 YEARS

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged ≥ 18 years – Patients with biliary duct stenosis with undetermined etiology – Patients with pancreatic duct stenosis with undetermined etiology – Patients with pancreatic duct distension with undetermined etiology – Patients with biliary or pancreatic gallstones after failure to endoscopic treatment Exclusion Criteria:

  • Patients with haemorrhagic disease or hemostasis and coagulation disorders (TP < 60%, TCA> 40 sec. and platelets < 60000/mm3). – Patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted. – Patients with biliary duct diameter < 3 mm – Patients with pancreatic duct diameter <3 mm

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital St. Joseph, Marseille, France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arthur Laquiere, Gastroenterologist – Hospital St. Joseph, Marseille, France
  • Overall Official(s)
    • ARTHUR LAQUIERE, MD, Principal Investigator, French Society of Digestive Endoscopy

Citations Reporting on Results

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Bar-Meir S, Rotmensch S. A comparison between peroral choledochoscopy and endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1987 Feb;33(1):13-4. doi: 10.1016/s0016-5107(87)71476-x.

Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Hafner M, Costamagna G, Deviere J, Neuhaus H, Caillol F, Giovannini M, Hassan C, Dumonceau JM. Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy. 2015 Aug;47(8):739-53. doi: 10.1055/s-0034-1392584. Epub 2015 Jul 6.

Urakami Y, Seifert E, Butke H. Peroral direct cholangioscopy (PDCS) using routine straight-view endoscope: first report. Endoscopy. 1977 Mar;9(1):27-30. doi: 10.1055/s-0028-1098481.

Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.

Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.

Rey JW, Hansen T, Dumcke S, Tresch A, Kramer K, Galle PR, Goetz M, Schuchmann M, Kiesslich R, Hoffman A. Efficacy of SpyGlass(TM)-directed biopsy compared to brush cytology in obtaining adequate tissue for diagnosis in patients with biliary strictures. World J Gastrointest Endosc. 2014 Apr 16;6(4):137-43. doi: 10.4253/wjge.v6.i4.137.

Navaneethan U, Hasan MK, Lourdusamy V, Njei B, Varadarajulu S, Hawes RH. Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review. Gastrointest Endosc. 2015 Oct;82(4):608-14.e2. doi: 10.1016/j.gie.2015.04.030. Epub 2015 Jun 10.

Boyer J. [Endoscopic sphincterotomy and lithiasis of the common bile duct. Reality and perspectives]. Gastroenterol Clin Biol. 1993;17(4):241-3. No abstract available. French.

Seelhoff A, Schumacher B, Neuhaus H. Single operator peroral cholangioscopic guided therapy of bile duct stones. J Hepatobiliary Pancreat Sci. 2011 May;18(3):346-9. doi: 10.1007/s00534-010-0360-7.

Arnelo U, Siiki A, Swahn F, Segersvard R, Enochsson L, del Chiaro M, Lundell L, Verbeke CS, Lohr JM. Single-operator pancreatoscopy is helpful in the evaluation of suspected intraductal papillary mucinous neoplasms (IPMN). Pancreatology. 2014 Nov-Dec;14(6):510-4. doi: 10.1016/j.pan.2014.08.007. Epub 2014 Sep 27.

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