Endoclip Papillaplasty Restores Sphincter of Oddi Function
Endoclip Papillaplasty Restores Sphincter of Oddi Function
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.
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.
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.