NCT03795584

Endoclip Papillaplasty Restores Sphincter of Oddi Function

Status unknown Last updated 5 August 2020

What this trial tests

trial testing sterile repositionable hemostasis clipping device close the large duodenal papilla incision in Sphincter of Oddi Function in 30 participants. Status unknown.

Timeline

1 May 2018

Primary endpoint
21 March 2019

1 May 2021

Quick facts

Lead sponsor	Peking University Third Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 May 2018
Primary completion	21 March 2019
Estimated completion	1 May 2021
Sites	1 location across China

Drugs / interventions tested

• sterile repositionable hemostasis clipping device close the large duodenal papilla incision

Conditions studied

• Sphincter of Oddi Function — all drugs for Sphincter of Oddi Function →

Sponsor

Peking University Third Hospital

Who can join

Adults 18 to 85, any sex, with Sphincter of Oddi Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.