A Phase 3 interventional study of ERCP with SEMS plus radiofrequency ablation and ERCP with SEMS alone (standard of care) in Pancreatic Cancer and Unresectable Biliary-pancreatic Malignancies, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. The investigators will also look at the safety of the combination treatment, and see which treatment is better. In either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.
Device: ERCP with SEMS plus radiofrequency ablation
Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.
Device: ERCP with SEMS alone (standard of care)
Also known as: self expandable metal stents, co-axial stent placement
Also known as: self expandable metal stents, co-axial stent placement
Rate of Failure
Time frame: 180 days
Rate of Stent Patency
Time frame: 1 and 3 months post procedure
Incidence of Procedure Related Complications
Time frame: 1 month
| Milestone | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) |
|---|---|---|
| Started | 13 | 11 |
| Completed | 13 | 11 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Up to 180 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ERCP With SEMS Plus Radiofrequency Ablation | 12/13 (92.3%) | 4/13 (30.8%) | 13/13 (100%) |
| ERCP With SEMS Alone (Standard of Care) | 11/11 (100%) | 4/11 (36.4%) | 11/11 (100%) |
| Event | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) |
|---|---|---|
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 0/13 | 1/11 |
| Duodenal hemorrhageGastrointestinal disorders | 0/13 | 1/11 |
| Thromboembolic eventVascular disorders | 0/13 | 1/11 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 0/13 | 1/11 |
| HemorrhoidsGastrointestinal disorders | 0/13 | 1/11 |
| Blood bilirubin increasedInvestigations | 0/13 | 1/11 |
| Neoplasms ben/mal/unk (inc cyst/polyp) Other, specNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/13 | 0/11 |
| ColitisGastrointestinal disorders | 1/13 | 0/11 |
| Hepatobiliary disorders - Other, specifyHepatobiliary disorders | 1/13 | 0/11 |
| Abdominal painGastrointestinal disorders | 1/13 | 0/11 |
| Event | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 13/13 | 11/11 |
| HypocalcemiaMetabolism and nutrition disorders | 13/13 | 10/11 |
| HyperglycemiaMetabolism and nutrition disorders | 13/13 | 11/11 |
| HypoalbuminemiaMetabolism and nutrition disorders | 13/13 | 11/11 |
| Blood bilirubin increasedInvestigations | 10/13 | 11/11 |
| Alkaline phosphatase increasedInvestigations | 11/13 | 11/11 |
| Aspartate aminotransferase increasedInvestigations | 12/13 | 11/11 |
| INR increasedInvestigations | 12/13 | 9/11 |
| Alanine aminotransferase increasedInvestigations | 11/13 | 10/11 |
| Platelet count decreasedInvestigations | 11/13 | 7/11 |
| Age, Continuous(years) | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) | Total |
|---|---|---|---|
| Mean | 62.5 (42 to 84) | 57.9 (44 to 69) | 60.4 (42 to 84) |
| Sex: Female, Male(Participants) | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 8 | 6 | 14 |
| Ethnicity (NIH/OMB)(Participants) | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 11 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 11 | 9 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | ERCP With SEMS Plus Radiofrequency Ablation | ERCP With SEMS Alone (Standard of Care) | Total |
|---|---|---|---|
| United States | 13 | 11 | 24 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center