Clinical trial NCT04406961: Endoscopic Transpapillary Interventions.
Official title: Endoscopic Transpapillary Antegrade Sphincterotomy Developed by Dr. Dovbenko.(ASD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Surgery
Keywords: endoscopic transpapillary antegrade sphincterotomy (ASD)
antegrade sphincterotome
preservation of the function of the sph. of Oddi
avoid cholecystectomy
Lead sponsor: Military Medical Clinical Center of the Southern Region, Ukraine
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 102
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the anatomical justification of the structure of the sphincter of Oddi. The technique of sphincterotomy with dissection of only the circular muscle layer of the sphincter of Oddi has been developed. A new knife design has been developed for this technique. The confidence interval and relative risk of complications was determined in patients who are treated with standard methods or with the new method of Dr. Dovbenko.
Primary purpose: TREATMENT

Brief summary: The aim of the research has become to create a sphincterotome and a method that takes into account the anatomical structure of the sph Oddi. The disadvantages of pull-type sphincterotome led to develop a new sphincterotome. The characteristic features of new antegrade sphincterotome are: it is inserted ready to use; the direction of cutting is strictly determined; fully controlled depth of the cut. Thanks to shaping as it hook the sphincterotome has been extracted cutting the circular layer only. The cutting wire is located between two teflon catheters preventing the longitudinal muscle layer from being damaged. The distance between the catheters determines the depth of the cut. Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko -(ASD) performance in such case allowed: to manage the papillary stenosis; to treat complicated form of gallstone disease; In research group this method allowed to avoid cholecystectomy in 71,2 % of cases

Detailed description: Sph of Oddi consists of a circular inner muscle layer and a longitudinal outer muscle layer. The circular layer does not depend on the duodenum. The longitudinal layer passes from the wall of the duodenum and separates ascending and descending parts superimposing over its circular layer. The arrangement of these layers towards each others is constant. Mostly ERCP complications are caused by the interventions in major papilla and remain at a high level of frequency up to 23 % Cutting all the layers of duodenum leads to bleeding up to 3 %. The perforation might happened up to 1 % Destruction of the opening mechanism after sphincterotomy leads to develop of reflux cholangitis, acute cholecystitis. It is possible to avoid further cholecystectomy only in 10% of patients. Incapability of performing the retrograde sphincterotomy in patients with extended papillary stenosis led to the creation of a new method - ASD. Retrograde and antegrade sphincterotomies are analysed. 750 patients underwent ASD within 7 years 65 % in urgent cases . Relative risk of complication after ASD performing 3 times less. Taking into consideration possible post-ASD inner edema, plastic biliary/pancreatic stent(s) are required during 5-10 days after. Standard methods for post ERCP pancreatitis prevention must be applied in all cases. The new method performed some selective. First of all young patient with alone stone in the common bile duct, women after after childbirth. secondly, elderly patient were cured by ASD. And as well as a group of patients with severe comorbid diseases, such as renal failure, acute myocardial infarction. In our research, in two patients with AIDS was performed ASD. They were on special treatment after being diagnosed with HIV-infection, within 2 years. It was SSC. Papillary stenosis and cholangiolithiasis were cured successfully. The use of ASD with preservation of the closure function of the sph. Oddi allowed to avoid cholecystectomy in 71.2%. ASD can be performed new design of sphincterotome. It takes into account the anatomical structure of sph. Oddi and is recommended as an alternative to standard sphincterotomy, balloon dilatation and drainage interventions (RR 0,55 \[95%CI 0,18 to 1,67\]. ASD must be performed by an endoscopist with experience in transpapillary intervention.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach and duodenum for the introduction of a duodenoscope to the major duodenal papilla.

Exclusion Criteria:

The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.

Primary outcomes:
measure: The number of participants with the complete removal of stones from bile ducts.
timeFrame: During the procedure.
measure: The number of participants with acute pancreatitis.
timeFrame: Up to 12 hours after the procedure.
measure: The number of participants with acute bleeding.
timeFrame: From during the procedure to two days after the procedure.
measure: The number of participants with perforation of duodenum.
timeFrame: From one to 3 days after the procedure.
Secondary outcomes:
measure: The number of participants with restenosis.
timeFrame: From 1 to 5 years after the procedure.
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: Oleg Dovbenko
state: Odessa Region
Study officials:
References: