Sphincter of Oddi Function Clinical Trial
Official title:
Endoscopic Sphincterotomy (EST) for Bile Duct Gallstones Cause Damage to the Ampulla of Vater and Sphincter of Oddi (SO): Endoclip Papillaplasty Help Recover the Damaged SO Function and Possibly Prevent Gallstone Recurrence
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.Briefly, the operator assessed the patulous biliary opening and ductal axis,
positioned and adjusted eachendoclip in order to close the patulous opening
In order to reduce PEP risk, a rectal non-steroidal anti-inflammatory drug was administered
30 minutes before the ERCP in all patients. As the standard of care at the study hospital,
the patients swallowed 2% lidocaine hydrochloride gel for local pharyngeal anesthesia, and 10
mg of diazepam were injected intramuscularly before ERCP. Anti-convulsants were not allowed.
ERCP was performed in a standard manner using a side-viewing endoscope.
After successful selective deep cannulation of the common bile duct with a guidewire, the
guidewire was extracted, and SOM was performed before contrast agent was introduced to
determine the margins of the choledocholithiasis.
EST was performed, and the size of EST, which was large incision (incision to the full part
of the ampulla) or long enough to ensure successful stone extraction, depended on the
transverse diameter of the stones.
After stones removal, a 7.5Fr×26 cm biliary plastic stent, which was a suspended overlong
biliary stent formed from a nasobiliary drainage tube (Boston Scientific), was placed to
ensure that the biliary duct would not be clipped during endoclip papillaplasty and to reduce
duodenobiliary reflux during the next 3-week before follow-up.
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. The stent will be
romoved with Allis clamp 3 weeks after the procedure.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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03795584 -
Endoclip Papillaplasty Restores Sphincter of Oddi Function
|