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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03795584
Other study ID # HYH20180520
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date May 1, 2021

Study information

Verified date August 2020
Source Peking University Third Hospital
Contact Yonghui Huang, MD
Phone 86-10-13911765322
Email 13911765322@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 1, 2021
Est. primary completion date March 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Peking University Third Hosptial Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SO manometric data The comparison of the SO manometric data before and after the procedure Before operation?During operation?Three weeks after operation
Secondary Frequency of use of ML and the incidence of adverse events Measure the frequency of use of ML and the incidence of adverse events, and to evaluate the healing of the ampulla. Three weeks after operation
See also
  Status Clinical Trial Phase
Recruiting NCT04183036 - Endoclip Papillaplasty Recover Sphincter of Oddi Function After Endoscopic Sphincterotomy for Bile Duct Gallstones N/A