A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP
NCT ID: NCT03416205
Last Updated: 2018-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2017-07-20
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EST
EST is an operation using the Erbao electric knife and Three-cavity incision knife to make a large incision to the duodenal nipples，and the incision scope is the nipple mouth uplift length of 4/5. It has been used since 1974. The technique is intuitive and intact. However, EST cut too small to achieve the purpose of treatment and will affect the next step, and if the incision is too large it may be easier to occur gastrointestinal perforation and bleeding.The EST will also damage the anatomy of the Oddi sphincter structure,which causes bacterial reflux to the bile duct, the recurrence of CBD.Some surgeons prefer it because it's postoperative pancreatitis rate is lower and it may be easier to find the lesion position if bleeding or perforation occurs.
Erbao electric knife
Erbao electric knife is used to cut the Duodenal sphincter
Three-cavity incision knife
Three-cavity incision knife is used to cut the Duodenal sphincter
EPBD
EPBD is an operation using the Columnar expansion balloon to expand duodenal to achieve the purpose of using the basket and other instruments to take stone out. Balloon expansion may retain part of the sphincter not destroyed, and basically retain the normal physiological function of the nipple sphincter.Thus it may reduce the risk of recurrence of stones and bacterial reflux. However,the postoperative pancreatitis rate is high(4.8% -19.5% ), and nipple sphincter tear is uncontrollable in EPBD.If the digestive tract perforation or bleeding occur after EPBD,it is hard to accurately find the lesion position.Some surgeons prefer it for it's lower bleeding and perforation rate.
Columnar expansion balloon
Columnar expansion balloon is used to expand the the Duodenal sphincter
sEST+EPBD
sEST+EPBD is an operation combining EST and EPBD. Investigators use the Erbao electric knife and Three-cavity incision knife to make a small incision to the duodenal nipples, and the incision length is less than 5mm while the incision scope is less than the nipple mouth uplift length of 1/2. Then, Investigators match the appropriate Columnar expansion balloon according to the diameter of the common bile duct and gradually expand the duodenal nipples.This method allows the nipple sphincter to be cut in a small range, then the balloon can guide the direction of the nipple sphincter tearing after the expansion , so that the digestive tract bleeding, perforation may be smaller and more controllable. Besides,it may reduce postoperative pancreatitis rate and the recurrence rate of stones.
Erbao electric knife
Erbao electric knife is used to cut the Duodenal sphincter
Three-cavity incision knife
Three-cavity incision knife is used to cut the Duodenal sphincter
Columnar expansion balloon
Columnar expansion balloon is used to expand the the Duodenal sphincter
Interventions
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Erbao electric knife
Erbao electric knife is used to cut the Duodenal sphincter
Three-cavity incision knife
Three-cavity incision knife is used to cut the Duodenal sphincter
Columnar expansion balloon
Columnar expansion balloon is used to expand the the Duodenal sphincter
Eligibility Criteria
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Inclusion Criteria
* CT or MRCP diagnose the patients with Common bile duct stones
* The diameter of the stone is less than or equal to 1.5cm
* Patients with the indications for ERCP
* Patients and their families agree to participate in the trial
Exclusion Criteria
* A history of gastrointestinal surgery
* ERCP and EST or EPBD surgery history
* Patients generally poor, total bilirubin\> 200umol / L or PT time extension\> 3s
* Patients with mental illness or other serious heart and lung disease
20 Years
80 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Zhujiang Hospital
OTHER
Responsible Party
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Principal Investigators
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Changhui Yu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Locations
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Zhujiang Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2017-XHNK-001
Identifier Type: -
Identifier Source: org_study_id
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