Lesions of Biliary or Wirsung DuctsNCT03190343

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

An observational study of Lesions of Biliary or Wirsung Ducts and Biliary Tract Diseases, run by Hospital St. Joseph, Marseille, France at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lesions of Biliary or Wirsung Ducts, Biliary Tract Diseases, Common Bile Duct Diseases
What is being tested?: cholangio-pancreatoscopy
Type of treatment: Surgery or procedure
How many people: 67 participants
Where: 3 sitesFrance
Study dates: Nov 2016to Jan 2020
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

France3 sites

Hopital Mermoz
Lyon, 69008
Hopital Saint Joseph
Marseille, 13008
Centre Hospitalier Jacques Lacarin
Vichy, 03200

Other trials in France

About this study

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

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
Being tested: cholangio-pancreatoscopy
Medical subject headings: Biliary Tract Diseases, Common Bile Duct Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cholangio-pancreatoscopyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jan 2020

First posted16 Jun 2017
Study startNov 2016
Primary completion28 Jan 2019
Study completionJan 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Lesions of Biliary or Wirsung DuctsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 67 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03190343
Sponsor's protocol ID: CCTIRS 16-351
Status last verified: Apr 2019
First submitted: 14 Jun 2017
Last updated: 4 Apr 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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. doi: 10.1097/00000658-199610000-00005.
PubMed 8857851
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.
PubMed 3557026
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.
PubMed 26147492
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.
PubMed 862583
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.
PubMed 21737076
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.
PubMed 21419408
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.
PubMed 24748921
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.
PubMed 26071061
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.
PubMed 8339881
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.
PubMed 21480000
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.
PubMed 25287157
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.
PubMed 33095075

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "
ClinicalTrials.gov ID: NCT03190343
Acronym / sponsor ID: CCTIRS 16-351
Conditions: Lesions of Biliary or Wirsung Ducts, Biliary Tract Diseases, Common Bile Duct Diseases, Pancreatic Duct Disorder
Study type: Observational
Recruitment status: Unknown status
Enrolment: 67 participants (actual)
Lead sponsor: Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
Study start: Nov 2016 (actual)
Primary completion: 28 Jan 2019 (actual)
Study completion: Jan 2020 (estimated)
First posted: 16 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cholangio-pancreatoscopy	Procedure or surgery	–

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Results publication: PubMed 8857851Nakeeb 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. doi: 10.1097/00000658-199610000-00005.
Results publication: PubMed 3557026Bar-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.
Results publication: PubMed 26147492Tringali 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.
Results publication: PubMed 862583Urakami 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.
Results publication: PubMed 21737076Ramchandani 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.
Results publication: PubMed 21419408Draganov 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.
Results publication: PubMed 24748921Rey 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.
Results publication: PubMed 26071061Navaneethan 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.
Results publication: PubMed 8339881Boyer 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.
Results publication: PubMed 21480000Seelhoff 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.
Results publication: PubMed 25287157Arnelo 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.
Derived from this study: PubMed 33095075Laquiere 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ARTHUR LAQUIERE, MD principal investigator

French Society of Digestive Endoscopy

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lesions of Biliary or Wirsung Ducts and Biliary Tract Diseases, run by Hospital St. Joseph, Marseille, France at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03190343, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.