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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
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Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.
ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic papillary large balloon dilation group | Active Comparator | Endoscopic papillary large balloon dilation to extract bile duct stones |
|
| Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group | Experimental | Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPLBD | Procedure | Endoscopic papillary large balloon dilation for Choledocholithiasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of complications | The incidence of complications | within 1 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of 1st session treatment | The success rate of 1st session treatment | within 1 months after the procedure |
| The rate of mechanical lithotripsy | The rate of mechanical lithotripsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Yang, Doctor | Contact | 086-13454132186 | yjf-1976@163.com | |
| Lei Lu | Contact | 086-13758268293 | zacharylu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zhang | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Fourth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23324454 | Background | Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013 Jan 17;13:15. doi: 10.1186/1471-230X-13-15. |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| Shanghai Fourth People's Hospital Tongji University | OTHER |
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| ELPBD+ESD | Procedure | Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis |
|
| within 1 months after the procedure |
| Total ercp times | Total ercp numbers | within 1 months after the procedure |
| Overall successful stone removal rate | Overall successful stone removal rate | within 1 months after the procedure |
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 31006 | China |
|
| D002769 | Cholelithiasis |