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
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stone removal (Saline 50ml each time) | Other | After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD stone removal via lithotripsy | Procedure | Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone fragments clearance | Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP cholangitis | Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections. | 3 months |
| Bleeding |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xun Li, MD,PhD | Hepatopancreatobiliary Surgery Institute of Gansu Province | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29610513 | Background | Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27. | |
| 21737076 |
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
| Saline 50ml | Procedure | If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time. |
|
| Saline +50ml | Procedure | If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance. |
|
Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl. |
| 3 months |
| Post-ERCP pancreatitis | Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure. | 3 months |
| Perforation | Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space. | 3 months |
| The procedure time | Was defined as the sum of times of all processes of endoscopic procedure. | 3 months |
| Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7. |
| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002761 | Cholangitis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001649 | Bile Duct Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided