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The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.
The main question it aims to answer is:
Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transpapillary stenting | Experimental | Patients will undergo prophylactic transpapillary gallbladder drainage followed by fully-covered self-expandable metal stent placement for biliary drainage |
|
| Standard biliary drainage | Active Comparator | Patients will undergo fully-covered self-expandable metal stent placement for biliary drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double plastic pigtail stent plus fully covered self-expandable metal stent | Device | After contrast injection, the cystic duct orifice will be detected. Using a sphincterotome, a 0.035-inch hydrophilic angled guidewire will be negotiated into the gallbladder. Dilation of the cystic duct will be performed using standard devices designed for biliary intervention, including pneumatic dilators or dilation progressive catheters. After dilation, a 7Fr plastic, double pigtail stent, length of 12 or 15 cm, will be deployed across the papilla. Finally, a fully-covered self-expandable metal stent will be placed alongside the gallbladder drainage for biliary drainage. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute cholecystitis | The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall adverse events | The overall adverse events rate will be calculated and compared between the two groups | 6 months |
| Hospitalization | The duration of the hospitalization will be calculated and |
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Inclusion Criteria:
Adult patients
Signed informed consent
Patients requiring covered metal stent placement for managing MBO
High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
presence of at least 2 of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Francesco Crinò, MD, PhD | Contact | 00390458126191 | stefanofrancesco.crino@aovr.veneto.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUI Verona | Verona | 37134 | Italy |
|
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Participants will be not informed about the treatment received
|
| Fully covered self-expandable metal stent | Device | After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage |
|
| 6 months |
| Disease-free survival | Acute cholecystitis free-survival rate, calculated as days from endoscopic retrograde cholangiopancreatography to acute cholecystitis or end of follow-up, cholecystectomy, or death, will be calculated and compared between the two groups | 6 months |
| Technical success | The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated | 1 mont |
| Procedure time | The time of the procedure, calculates ad minutes starting after randomization to the end of the procedure, will be calculated and compared between the teo groups | 1 month |