Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Larissa University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.
The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis) |
|
| 2 | Active Comparator | preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoendoscopic Rendez vous | Procedure | intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative hospital stay | from onset of intervention to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of CBD clearance | during ERCP | |
| failure rate of selective CBD cannulation | during ERCP | |
| incidence of multiple endoscopic procedures |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Tzovaras, MD | Contact | +30 2410 682730 | gtzovaras@hotmail.com | |
| Ioannis Baloyiannis, MD | Contact | +30 2410 682728 | balioan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Constantine Hatzitheofilou, MD | University of Thessaly, School of Medicine | Study Chair |
| George Tzovaras, MD | University of Thessaly, School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa | Recruiting | Larissa | Thessaly | 413 35 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22261836 | Derived | Tzovaras G, Baloyiannis I, Zachari E, Symeonidis D, Zacharoulis D, Kapsoritakis A, Paroutoglou G, Potamianos S. Laparoendoscopic rendezvous versus preoperative ERCP and laparoscopic cholecystectomy for the management of cholecysto-choledocholithiasis: interim analysis of a controlled randomized trial. Ann Surg. 2012 Mar;255(3):435-9. doi: 10.1097/SLA.0b013e3182456ec0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| preoperative ERCP and CBD clearance | Procedure | ERCP and CBD clearance followed by laparoscopic cholecystectomy |
|
| within 30 days |
| incidence of hyperamylasemia | within 48 hours post-ERCP |
| incidence of severe pancreatitis (APACHE II score >6) | within 48 hours post-ERCP |
| total hospital stay | from admission to discharge |
| complications other but pancreatitis | within 30 days |
| death | within 30 days |
| Ioannis Baloyiannis, MD |
| University Hospital of Larissa |
| Principal Investigator |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided