Endoscopic Transpapillary Interventions.

Not Applicable

• Conditions: Endoscopic Surgery

• Registration Number: NCT04406961
• Lead Sponsor: Military Medical Clinical Center of the Southern Region, Ukraine

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.

Study Timeline

• Study Start: 2003-01-21
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-24
• Study First Posted: 2020-05-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-23
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of participants with the complete removal of stones from bile ducts.	During the procedure.	Complete extraction of stones from the bile ducts is controlled by cholangiogram data.
The number of participants with acute pancreatitis.	Up to 12 hours after the procedure.	Participants suffering from acute pancreatitis after the procedure are considered. Participants suffered one or more symptoms: an increase in serum lipase or amylase above normal, abdominal pain that persists for 24 hours with the need to relieve pain.
The number of participants with acute bleeding.	From during the procedure to two days after the procedure.	Participants suffering from acute bleeding after sphincterotomy are considered. Bleeding after sphincterotomy with a drop in hemoglobin\> 2 g / dl and requires therapeutic and / or endoscopic methods to stop bleeding.
The number of participants with perforation of duodenum.	From one to 3 days after the procedure.	Clinical manifestation of duodenal perforation after procedure, confirmed by CT or surgery.

Secondary Outcome Measures

Name	Time	Method
The number of participants with restenosis.	From 1 to 5 years after the procedure.	Restenosis of the sphincter of Oddi is confirmed by CT or cholangiogram. The expansion of the diameter of the common bile duct should be more than 11 mm, and the total bilirubin is increased\> 60 mmol / L.

Trial Locations

Locations (1)

Oleg Dovbenko; 🇺🇦 Odessa, Odessa Region, Ukraine