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The Clinical Evaluation of Oddi Spincteroplasty With Blood Vessel Clamp After Iatrogenic Injury by ERCP

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ClinicalTrials.gov Identifier: NCT03795584
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Huang Yonghui, Peking University Third Hospital

Brief Summary:
Background: Since endoscopic sphincterotomy (EST) was first reported in 1974, endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred treatment for common bile duct stones. It has largely replaced traditional surgery. However, there are also many difficulties and risks in endoscopic stone removal of large common bile duct stones with a diameter of 1.5 cm or more. the ERCP method for taking large bile duct stones mainly includes EST, endoscopic papillary balloon dilation (EPBD), and mechanical lithotripsy (ML) up to now. For the large common bile duct stones with a diameter of ≥15mm, the most commonly used stone removal strategy is to remove stones after large balloon dilatation of the duodenal papilla. However, a large incision of the duodenal papilla or a small incision combined with large balloondilatation will improve the risk of postoperative bleeding, perforation and reflux. Large balloon dilatation of 1.8 cm can cause irreversible damage to the sphincter. The postoperative duodenal papilla is likely to be in a state of continuous openness. Bile duct reflux in the duodenal fluid can lead to recurrence of cholangiolithiasis and cholangitis. At present, there have been consensus on the occurrence of long-term repeated bile duct stones and cholangitis after large dilation or large incision of the duodenum.However there is no effective strategy to restore the structural integrity of the Sphincter of Oddi and reduce biliary duct complications secondary to loss of function. The aim of this study is to evaluate the efficacy of an innovative Oddi spincteroplasty strategy with Blood Vessel Clamp

Condition or disease Intervention/treatment Phase
Sphincter of Oddi Dysfunction Procedure: Vascular clip close the large duodenal papilla incision Not Applicable

Detailed Description:

The details of the procedure is listed as follows after successful removal of the large stone with diameter ≥15mm, which companied with arge incision of sphincter of Oddi biliary plastic stents and pancreatic stents will be placed into the commonbile duct and pancreatic duct, respectively. then vascular clamps will be applied to close the incision of the duodenal papilla, which could be effectively promote the healing of the opening of the duodenal papilla and prevent duodeno biliary reflux. One month later, the bile duct stent was removed under endoscopy to observe the healing of the duodenal papilla and the shedding of the stent.

Indications

1.Common bile duct stoneswith diameter≥15mm removed with ERCP

Contraindications

  1. There is upper gastrointestinal stenosis or obstruction, endoscopy can not reach the duodenal papilla
  2. There are contraindications to endoscopy such as cardiopulmonary insufficiency
  3. People with severe bleeding tendencies
  4. Unstable vital signs

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: EDPP requires nipple forming after biliary stent placement. To compare the difference between SOBS combined with EDPP, common biliary stent (OBS) combined with EDPP and the current recommended EST combined with EPBD, the patients were divided into three groups: ERCP+EST+SOBS+EDPP. ERCP+EST+OBS+EDPP . ERCP+EST+EPBD
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Evaluation of Oddi Spincteroplasty With Blood Vessel Clamp After Iatrogenic Injury by ERCP
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: experimental group
Vascular clip close the large duodenal papilla incision,suspended overlength biliary stents,Oddi sphincter manometry ,after EST , one month after surgery, one year after surgery
Procedure: Vascular clip close the large duodenal papilla incision
After the bile duct stent was placed, the investigators can use vascular clip to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.

Active Comparator: Control group
Vascular clip close the large duodenal papilla incision,common biliary stents,Oddi sphincter manometry ,after EST , one month after surgery, one year after surgery
Procedure: Vascular clip close the large duodenal papilla incision
After the bile duct stent was placed, the investigators can use vascular clip to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.

No Intervention: Blank control group
EST、EPBD、Oddi sphincter manometry ,after EST , one month after surgery, one year after surgery



Primary Outcome Measures :
  1. Manometry of sphincter of Oddi before operation [ Time Frame: After successful bile duct intubation immediately ]
    Measure preoperative sphincter of Oddi pressure after successful bile duct intubation in order to obtain the baseline pressure.

  2. Measurement of biliary pressure immediately after removal of stones [ Time Frame: immediately after successful stone extraction ]
    Measure postoperative sphincter of Oddi pressure immediately after successful EST and stone extraction.

  3. Manometry of sphincter of Oddi one month later after operation [ Time Frame: one month after the operation ]
    Measure sphincter of Oddi pressure one month later after the EST to evaluate the function of sphincter of Oddi



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Common bile duct stones removed with ERCP

Exclusion Criteria:

  1. There is upper gastrointestinal stenosis or obstruction, endoscopy can not reach the duodenal papilla
  2. There are contraindications to endoscopy such as cardiopulmonary insufficiency
  3. People with severe bleeding tendencies
  4. Unstable vital sign

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795584


Contacts
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Contact: Yonghui Huang, MD 86-10-13911765322 13911765322@163.com

Locations
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China, Beijing
Peking University Third Hosptial Recruiting
Beijing, Beijing, China, 100000
Contact: Yonghui Huang, archiater    13911765322    pskyq@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Yonghui Huang, MD Peking University Third Hosptial

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Responsible Party: Huang Yonghui, chief physician, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03795584     History of Changes
Other Study ID Numbers: HYH20180520
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sphincter of Oddi Dysfunction
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases