An interventional study of Habib™ EndoHBP in Adenoma, Bile Duct, sponsored by Hôpital Cochin. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-28.
Sponsored by Hôpital Cochin · Not applicable, Interventional, and Treatment
The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.
Hôpital Cochin is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Habib™ EndoHBP
During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.
number of residual neoplasia
Time frame: one year
presence of low grade dysplasia or high grade dysplasia or invasive carcinoma
Time frame: 6 months
number of surgery
Time frame: one year
fever
Time frame: 48 hours post endoscopic procedure
pain
Visual Analogue Scale
Time frame: 48 hours post endoscopic procedure
bleeding
hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin
Time frame: 48 hours post endoscopic procedure
acute pancreatitis
pain and increased of lipase more than 3 fold
Time frame: 48 hours post endoscopic procedure
cholangitis
fever and abnormal hepatic blood tests
Time frame: 48 hours post endoscopic procedure
perforation
pneumoperitoneum, retropneumoperitoneum, pneumothorax
Time frame: 48 hours post endoscopic procedure
No study locations are listed for this record.
Plan to share: No
The record gives a start of Nov 2012, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Adenoma, Bile Duct
Hôpital Cochin