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This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.
This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early double-guidewire technique (DGT) | Active Comparator | First arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation. |
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| delayed double-guidewire technique (DGT) | Active Comparator | In the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double-guidewire cannulation technique | Procedure | With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct. |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary cannulation success rate | The percentage of biliary cannulation success in both arms. | During the ERCP procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate morbidity | Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period. | From the start, until 30 minutes after completion of ERCP |
| Delayed morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ARTHUR LAQUIERE, MD | Société Française d'Endoscopie Digestive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Bercy | Charenton-le-Pont | 94220 | France | |||
| Hôpital Dupuytren |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15990812 | Result | Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available. | |
| 15672074 |
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Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the DGT immediately and the delayed arm uses the DGT only if 10 more minutes of conventional cannulation technique does not allow biliary cannulation.
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Morbidities occurring more than 30 minutes and up to 1 month after ERCP completion. Special attention will be taken for bowel perforation, gastrointestinal bleeding and acute pancreatitis
| 30 minutes after ERCP completion and up to 30 days |
| procedural time | The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation. | time from the first guidewire insertion into the pancreatic duct up to the end of cannulation. |
| Limoges |
| 87042 |
| France |
| Hopital Saint Joseph | Marseille | 13008 | France |
| Groupe Hospitalier Diaconesses - La Croix Saint-Simon | Paris | 75020 | France |
| Hôpital Haut Lévêque | Pessac | 33600 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier de Bigorre | Tarbes | 65013 | France |
| Centre Hospitalier de Vichy | Vichy | 03207 | France |
| Result |
| Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. doi: 10.1016/s0016-5107(04)02463-0. No abstract available. |
| 22219598 | Result | Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):5289-94. doi: 10.3748/wjg.v17.i48.5289. |
| 11577302 | Result | Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550. |
| 17581267 | Result | Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. doi: 10.1111/j.1572-0241.2007.01378.x. Epub 2007 Jun 20. |
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| 33860484 | Derived | Laquiere A, Privat J, Jacques J, Legros R, Urena-Campos R, Belkhodja H, Subtil C, Kanafi L, Lecomte L, Boustiere C, Katsogiannou M, Karsenti D. Early double-guidewire versus repeated single-guidewire technique to facilitate selective bile duct cannulation: a randomized controlled trial. Endoscopy. 2022 Feb;54(2):120-127. doi: 10.1055/a-1395-7485. Epub 2021 Apr 15. |