Sphincter of Oddi Function Clinical Trial
Official title:
Endoclip Papillaplasty Restores Sphincter of Oddi Function
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hosptial | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04183036 -
Endoclip Papillaplasty Recover Sphincter of Oddi Function After Endoscopic Sphincterotomy for Bile Duct Gallstones
|
N/A |