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A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416205
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Zhujiang Hospital

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE January 31, 2018
Last Update Posted Date March 19, 2018
Actual Study Start Date  ICMJE July 20, 2017
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
the incidence of composite events of infection, hemorrhage, perforation, pancreatitis [ Time Frame: 3 and 24 hours after the ERCP ]
Investigators comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally investigators use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
the incidence of composite events of infection, hemorrhage, perforation, pancreatitis [ Time Frame: 3 and 24 hours after the ERCP ]
We comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally we use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Recurrence rate of bile duct stones [ Time Frame: 1 year after the ERCP. ]
One year after the ERCP,the participants will have a CT scan to find out whether the bile duct stones recur again.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP
Official Title  ICMJE A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP: Comparison of EST, EPBD, and sEST+EPBD in Endoscopic Choledocholithiasis Treatment.
Brief Summary Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.
Detailed Description Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE ERCP
Intervention  ICMJE
  • Device: Erbao electric knife
    Erbao electric knife is used to cut the Duodenal sphincter
  • Device: Three-cavity incision knife
    Three-cavity incision knife is used to cut the Duodenal sphincter
  • Device: Columnar expansion balloon
    Columnar expansion balloon is used to expand the the Duodenal sphincter
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Device: Erbao electric knife
    • Device: Three-cavity incision knife
  • Experimental: 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.
    Intervention: Device: Columnar expansion balloon
  • Experimental: 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.
    Interventions:
    • Device: Erbao electric knife
    • Device: Three-cavity incision knife
    • Device: Columnar expansion balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 20-80 years old
  • 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:

  • Stones are too large (> 1.5cm)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03416205
Other Study ID Numbers  ICMJE 2017-XHNK-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhujiang Hospital
Study Sponsor  ICMJE Zhujiang Hospital
Collaborators  ICMJE Nanfang Hospital of Southern Medical University
Investigators  ICMJE
Principal Investigator: Changhui Yu, Doctor Zhujiang Hospital
PRS Account Zhujiang Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP