Benign Neoplasm of Liver and/or Biliary DuctsNCT02057146
Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
A study testing Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy in people with Benign Neoplasm of Liver and/or Biliary Ducts and Neoplasm of Uncertain Behavior of Biliary System, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Benign Neoplasm of Liver and/or Biliary Ducts, Neoplasm of Uncertain Behavior of Biliary System, Benign Neoplasms of the Pancreas
- What is being tested?
- Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to 22 Aug 2019
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicious lesions of the hepatobiliary pancreatic duct systems.
Who cannot join
- Unwillingness to participate
- Unfit for the investigation
Trial locations and contacts
1 site in 1 country.
About this study
Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.
Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation of suspected premalignant lesions in the biliary duct and in the pancreas.
Read the detailed description
Diagnosis of early preneoplastic lesions is always a problem, but especially when it comes to hidden organs such as the bile ducts and the pancreas. The recent developments in endoscopy encompass mini endoscopes (mother-baby; "Spyglas®"), which allow visualization of the bile ducts and the pancreas and the possibility to take biopsies under direct vision. An even newer technique is an adaptation of the existing confocal laser scanning microscopy (CLSM) to a small probe, which fits into the 1 mm working channel of the Spyglas. This application of CLSM was coined probe-based confocal laser endomicroscopy (pCLE).
It is the aim of this project to systematically and prospectively evaluate the usefulness of pCLE in two distinct patient groups: patients with PSC prone to develop a bile duct cancer (CCC) and patients with chronic pancreatitis/family history of pancreatic cancer prone to develop pancreatic cancer or have suspected IPMN.
Patients\&Methods Patients with suspected diagnosis of PSC who have to undergo ERCP for diagnosis or therapy or suspected CCC will receive Spyglass investigations under a current clinical protocol. The investigators will add pCLE to these patients.
Patients with chronic (hereditary) pancreatitis and suspected malignancy, patients with suspected premalignant lesions (e.g. IPMN), and individuals at risk from familiar pancreatic cancer syndromes who under the surveillance (MRCP with secretin) demonstrate a pancreatic pathology will undergo ERCP with Spyglass as a diagnostic procedure. In these patients, the investigators will add pCLE.
Spyglass will be introduced during ERCP and the ducts will be visually inspected. In areas of stenosis and/or suspected pathology, pCLE will be executed. Finally, these areas will be biopsied, if possible. Bile and pancreatic juice will be taken for cytology and molecular analysis. Diagnostic yield and accuracy will be determined of ERCP (x-ray), Spyglas, CLSM, and histology (PAD).
This will be firstly an explorative study because the diagnostic criteria for assessing malignancy with CLSM are under development and the investigators group as one of the few doing Spyglas routinely will contribute to establishing such criteria. For statistical calculations, a total of 100 patients will be necessary. It is their plans to do this prospectively together with several centers once the diagnostic criteria are set in order to fulfill the statistical needed numbers.
Significance An early diagnosis of both CCC developing in PSC patients and PDAC developing in CP, IPMN patients or individuals with familiar history of PDAC would allow us to treat these patients in good time with surgery or transplantation (LTX). This, in turn, is the only way to improve the diagnosis of these tumors as the have amongst the worst prognosis of all solid tumors in man.
- Conditions
- Benign Neoplasm of Liver and/or Biliary Ducts, Neoplasm of Uncertain Behavior of Biliary System, Benign Neoplasms of the Pancreas, Neoplasms of the Pancreas
- Being tested
- Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy
- Keywords
- PSC, mother-baby endoscopy, ERCP, IPMN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopyProcedure or surgery
Also called Spyglass, Cellvizio, pCLE
The intervention consists of mother-baby endoscopy of the bile and/or pancreatic duct with visual inspection, confocal laser microscopy, collection of fluid for cytology, and eventually biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Mother-baby endoscopy | Experimental | Spyglass mother-baby endoscopy in conjunction with ERCP Receives: Procedure: Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.
Beside the safety, technical feasibility and efficacy, we will record and calculate the diagnostic accuray by comparing the outcome of Spyglass/pCLE (endoscopic judgement) with histology (biopsy) and eventual surgical pathology.
Outcome measures will be 1) diagnosis of malignant/suspicious lesion by Spyglass and/or pCLE versus final diagnosis with biopsy (Spyglass, other) and/or surgical pathology (resection).
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startOct 2013
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Neoplasm of Liver and/or Biliary DuctsStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Matthias Löhr, Karolinska University Hospital
- Investigators
- Matthias Löhr, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057146
- Sponsor's protocol ID
- 2013/1658-31
- Other IDs
- 2013/1658-31
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2014
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnelo U, Albiin N, Enochsson L, Meisner S, Permert J, Lundell L. Endoscopic evaluation of the pancreatic duct system: opportunities offered by novel technology. Scand J Gastroenterol. 2007 Aug;42(8):1018-20. doi: 10.1080/00365520601101526.
PubMed 17613934Arnelo U, Valente R, Scandavini CM, Halimi A, Mucelli RMP, Rangelova E, Svensson J, Schulick RD, Torphy RJ, Fagerstrom N, Moro CF, Vujasinovic M, Matthias Lohr J, Del Chiaro M. Intraoperative pancreatoscopy can improve the detection of skip lesions during surgery for intraductal papillary mucinous neoplasia: A pilot study. Pancreatology. 2023 Sep;23(6):704-711. doi: 10.1016/j.pan.2023.06.006. Epub 2023 Jun 12.
PubMed 37336668Lohr JM, Lonnebro R, Stigliano S, Haas SL, Swahn F, Enochsson L, Noel R, Segersvard R, Del Chiaro M, Verbeke CS, Arnelo U. Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center prospective study in 45 patients. United European Gastroenterol J. 2015 Dec;3(6):551-60. doi: 10.1177/2050640615579806.
PubMed 26668748
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
- ClinicalTrials.gov ID
- NCT02057146
- Acronym / sponsor ID
- 2013/1658-31
- Conditions
- Benign Neoplasm of Liver and/or Biliary Ducts, Neoplasm of Uncertain Behavior of Biliary System, Benign Neoplasms of the Pancreas, Neoplasms of the Pancreas
- Keywords
- PSC, mother-baby endoscopy, ERCP, IPMN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Oct 2013
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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.
Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.
Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation of suspected premalignant lesions in the biliary duct and in the pancreas.
Detailed description
Diagnosis of early preneoplastic lesions is always a problem, but especially when it comes to hidden organs such as the bile ducts and the pancreas. The recent developments in endoscopy encompass mini endoscopes (mother-baby; "Spyglas®"), which allow visualization of the bile ducts and the pancreas and the possibility to take biopsies under direct vision. An even newer technique is an adaptation of the existing confocal laser scanning microscopy (CLSM) to a small probe, which fits into the 1 mm working channel of the Spyglas. This application of CLSM was coined probe-based confocal laser endomicroscopy (pCLE).
It is the aim of this project to systematically and prospectively evaluate the usefulness of pCLE in two distinct patient groups: patients with PSC prone to develop a bile duct cancer (CCC) and patients with chronic pancreatitis/family history of pancreatic cancer prone to develop pancreatic cancer or have suspected IPMN.
Patients\&Methods Patients with suspected diagnosis of PSC who have to undergo ERCP for diagnosis or therapy or suspected CCC will receive Spyglass investigations under a current clinical protocol. The investigators will add pCLE to these patients.
Patients with chronic (hereditary) pancreatitis and suspected malignancy, patients with suspected premalignant lesions (e.g. IPMN), and individuals at risk from familiar pancreatic cancer syndromes who under the surveillance (MRCP with secretin) demonstrate a pancreatic pathology will undergo ERCP with Spyglass as a diagnostic procedure. In these patients, the investigators will add pCLE.
Spyglass will be introduced during ERCP and the ducts will be visually inspected. In areas of stenosis and/or suspected pathology, pCLE will be executed. Finally, these areas will be biopsied, if possible. Bile and pancreatic juice will be taken for cytology and molecular analysis. Diagnostic yield and accuracy will be determined of ERCP (x-ray), Spyglas, CLSM, and histology (PAD).
This will be firstly an explorative study because the diagnostic criteria for assessing malignancy with CLSM are under development and the investigators group as one of the few doing Spyglas routinely will contribute to establishing such criteria. For statistical calculations, a total of 100 patients will be necessary. It is their plans to do this prospectively together with several centers once the diagnostic criteria are set in order to fulfill the statistical needed numbers.
Significance An early diagnosis of both CCC developing in PSC patients and PDAC developing in CP, IPMN patients or individuals with familiar history of PDAC would allow us to treat these patients in good time with surgery or transplantation (LTX). This, in turn, is the only way to improve the diagnosis of these tumors as the have amongst the worst prognosis of all solid tumors in man.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-baby endoscopy | Experimental | Procedure: Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopySpyglass mother-baby endoscopy in conjunction with ERCP |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspicious lesions of the hepatobiliary pancreatic duct systems.
Key exclusion criteria (2 listed)
- Unwillingness to participate
- Unfit for the investigation
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 |
|---|---|---|
| Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopyAlso: Spyglass, Cellvizio, pCLEThe intervention consists of mother-baby endoscopy of the bile and/or pancreatic duct with visual inspection, confocal laser microscopy, collection of fluid for cytology, and eventually biopsy. | Procedure or surgery | Mother-baby endoscopy |
Primary outcome
Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.
Time frame: Two years
Beside the safety, technical feasibility and efficacy, we will record and calculate the diagnostic accuray by comparing the outcome of Spyglass/pCLE (endoscopic judgement) with histology (biopsy) and eventual surgical pathology. Outcome measures will be 1) diagnosis of malignant/suspicious lesion by Spyglass and/or pCLE versus final diagnosis with biopsy (Spyglass, other) and/or surgical pathology (resection).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 17613934Arnelo U, Albiin N, Enochsson L, Meisner S, Permert J, Lundell L. Endoscopic evaluation of the pancreatic duct system: opportunities offered by novel technology. Scand J Gastroenterol. 2007 Aug;42(8):1018-20. doi: 10.1080/00365520601101526.
- Results publication: PubMed 37336668Arnelo U, Valente R, Scandavini CM, Halimi A, Mucelli RMP, Rangelova E, Svensson J, Schulick RD, Torphy RJ, Fagerstrom N, Moro CF, Vujasinovic M, Matthias Lohr J, Del Chiaro M. Intraoperative pancreatoscopy can improve the detection of skip lesions during surgery for intraductal papillary mucinous neoplasia: A pilot study. Pancreatology. 2023 Sep;23(6):704-711. doi: 10.1016/j.pan.2023.06.006. Epub 2023 Jun 12.
- Results publication: PubMed 26668748Lohr JM, Lonnebro R, Stigliano S, Haas SL, Swahn F, Enochsson L, Noel R, Segersvard R, Del Chiaro M, Verbeke CS, Arnelo U. Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center prospective study in 45 patients. United European Gastroenterol J. 2015 Dec;3(6):551-60. doi: 10.1177/2050640615579806.
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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.
Matthias Löhr, Professor principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy in people with Benign Neoplasm of Liver and/or Biliary Ducts and Neoplasm of Uncertain Behavior of Biliary System, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions. (time frame: Two 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 NCT02057146, which also lists 3 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 24 Oct 2023.