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Endoclip Papillaplasty Restores Sphincter of Oddi Function

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ClinicalTrials.gov Identifier: NCT03795584
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Huang Yonghui, Peking University Third Hospital

Brief Summary:

Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.

Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.


Condition or disease Intervention/treatment
Sphincter of Oddi Function Procedure: sterile repositionable hemostasis clipping device close the large duodenal papilla incision

Detailed Description:

Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.

Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.

The investigators will recruit patients according to admission criteria and exclusion criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. Complications including perforation, bleeding, and PEP were recorded. Blood routine, pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase, aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested at 4 and 24 h after ERCP. All participants were followed at 3 weeks. Symptoms were examined and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi monitoring through duodenoscope.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endoclip Papillaplasty Restores Sphincter of Oddi Function
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 21, 2019
Estimated Study Completion Date : May 1, 2021

Group/Cohort Intervention/treatment
Endoclip papillaplasty
Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized.
Procedure: sterile repositionable hemostasis clipping device close the large duodenal papilla incision
After the bile duct stent was placed, the investigators can use sterile repositionable hemostasis clipping device to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.




Primary Outcome Measures :
  1. SO manometric data [ Time Frame: Before operation、During operation、Three weeks after operation ]
    The comparison of the SO manometric data before and after the procedure


Secondary Outcome Measures :
  1. Frequency of use of ML and the incidence of adverse events [ Time Frame: Three weeks after operation ]
    Measure the frequency of use of ML and the incidence of adverse events, and to evaluate the healing of the ampulla.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This was a prospective pilot study of consecutive patients with CBD gallstones (transverse diameter ≥10 mm) who were treated at the Gastroenterology Department of Peking University Third Hospital by large-EST combined with endoclip papilloplasty between May 2018 and March 2019.
Criteria

Inclusion Criteria:

- 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter)

Exclusion Criteria:

  1. gallstone transverse diameter >35 mm, which is not appropriate to be extracted;
  2. history of previous sphincterotomy, previous EPBD;
  3. accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet therapy, or Billroth II or Roux-en-Y reconstruction;
  4. papilla located deep within a diverticulum;
  5. small papilla and short intramural segment, which was not suitable for large EST;
  6. medications known to affect the SO (calcium channel blockers, nitrates, opiates, and anticholinergics) taken within 48 h of the procedure;
  7. benign or malignant biliary stricture.

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    
Other Study ID Numbers: HYH20180520
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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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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Hemostatics
Coagulants