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

NCT03190343 | Unknown

• 1 other identifier: CCTIRS 16-351
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 3

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.

  4 YEARS

Interventions

cholangio-pancreatoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (3)

Hopital Mermoz

Lyon, 69008, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier Jacques Lacarin

Vichy, 03200, France

Location

Related Publications (12)

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  PMID: 8857851 RESULT

• 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.

  PMID: 3557026 RESULT

• 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.

  PMID: 26147492 RESULT

• 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.

  PMID: 862583 RESULT

• 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.

  PMID: 21737076 RESULT

• 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.

  PMID: 21419408 RESULT

• 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.

  PMID: 24748921 RESULT

• 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.

  PMID: 26071061 RESULT

• 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.

  PMID: 8339881 RESULT

• 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.

  PMID: 21480000 RESULT

• 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.

  PMID: 25287157 RESULT

• Laquiere AE, Privat J, Fumex F, Grandval P, Lecomte L, Curel L, Belle A, Trottier-Tellier F, Urena-Campos R, Penaranda G, Boustiere C, Napoleon 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.

  PMID: 33095075 DERIVED

MeSH Terms

Conditions

Biliary Tract Diseases; Common Bile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Bile Duct Diseases

Study Officials

• ARTHUR LAQUIERE, MD

  French Society of Digestive Endoscopy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: November 1, 2016
• Primary Completion: January 28, 2019
• Study Completion: January 1, 2020
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)