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

• ClinicalTrials.gov Identifier: NCT03190343
• Recruitment Status: Unknown
• First Posted: June 16, 2017
• Last Update Posted: April 4, 2019
• Sponsor: Hospital St. Joseph, Marseille, France
• Information provided by (Responsible Party): Arthur Laquiere, Hospital St. Joseph, Marseille, France

Tracking Information

• First Submitted Date: June 14, 2017
• First Posted Date: June 16, 2017
• Last Update Posted Date: April 4, 2019
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: January 28, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 14, 2017): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases
• Official Title: Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "

Brief Summary

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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.

• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

Condition

• Lesions of Biliary or Wirsung Ducts
• Biliary Tract Diseases
• Common Bile Duct Diseases
• Pancreatic Duct Disorder

• Intervention: Procedure: cholangio-pancreatoscopy
• Study Groups/Cohorts: Not Provided

Publications *

• Nakeeb A, Pitt HA, Sohn TA, Coleman J, Abrams RA, Piantadosi S, Hruban RH, Lillemoe KD, Yeo CJ, Cameron JL. Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann Surg. 1996 Oct;224(4):463-73; discussion 473-5.
• Bar-Meir S, Rotmensch S. A comparison between peroral choledochoscopy and endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1987 Feb;33(1):13-4.
• Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Häfner M, Costamagna G, Devière 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. Review.
• Urakami Y, Seifert E, Butke H. Peroral direct cholangioscopy (PDCS) using routine straight-view endoscope: first report. Endoscopy. 1977 Mar;9(1):27-30.
• 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, Dümcke 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. Review.
• Boyer J. [Endoscopic sphincterotomy and lithiasis of the common bile duct. Reality and perspectives]. Gastroenterol Clin Biol. 1993;17(4):241-3. Review. 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. Review.
• Arnelo U, Siiki A, Swahn F, Segersvärd R, Enochsson L, del Chiaro M, Lundell L, Verbeke CS, Löhr 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.
• Laquière AE, Privat J, Fumex F, Grandval P, Lecomte L, Curel L, Belle A, Trottier-Tellier F, Urena-Campos R, Penaranda G, Boustière C, Napoléon B. Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study. Scand J Gastroenterol. 2020 Nov;55(11):1381-1388. doi: 10.1080/00365521.2020.1832143. Epub 2020 Oct 23.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: April 3, 2019): 67
• Original Estimated Enrollment (submitted: June 14, 2017): 60
• Estimated Study Completion Date: January 2020
• Actual Primary Completion Date: January 28, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03190343
• Other Study ID Numbers: CCTIRS 16-351
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Arthur Laquiere, Hospital St. Joseph, Marseille, France
• Study Sponsor: Hospital St. Joseph, Marseille, France
• Collaborators: Not Provided

Investigators

• Principal Investigator: ARTHUR LAQUIERE, MD; French Society of Digestive Endoscopy

• PRS Account: Hospital St. Joseph, Marseille, France
• Verification Date: April 2019