Endoscopic Transpapillary Interventions.

Endoscopic Transpapillary Antegrade Sphincterotomy Developed by Dr. Dovbenko.(ASD)

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

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Surgery
• Intervention / Treatment: Procedure: Endoscopic sphincterotomy.; Device: The standard sphincterotome.; Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.; Device: The antegrade sphincterotome developed by Dr. Dovbenko.

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 Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oleg Dovbenko, MD; Phone Number: +380682539685; Email: dovbenko2015@hotmail.com
• Study Contact Backup: Name: Oleg Dovbenko, MD; Phone Number: +380503161054; Email: dovbenko2015@hotmail.com

Study Locations

• Ukraine
  • Odessa Region
    • Odessa, Odessa Region, Ukraine, 65044
      • Recruiting
      • Oleg Dovbenko
      • Contact: Oleg Dovbenko, MD; Phone Number: +380503161054; Email: dovbenko2015@hotmail.com
      • Contact: Oleg Dovbenko, MD; Phone Number: +380682539685; Email: dovbenko73@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 102 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard sphincterotomy.; Standard retrograde sphincterotomy is performed on 750 patients using a standard sphincterotome. After deep bile duct cannulation, the standard sphincterotome, the Erlangen "pull-type" model, retrogradely cuts all layers of the wall of the duodenum and sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve insert standard sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.	Procedure: Endoscopic sphincterotomy.; Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct.; Device: The standard sphincterotome.; The standard sphincterotome, the Erlangen "pull-type" model, consists of a catheter containing a cautery wire exposed 15 to 25 mm near the tip of the instrument. The leading tip distal to the wire, the "nose," is 5 to 10 mm in diameter. After deep bile duct cannulation, the sphincterotome is retracted slowly, until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made by lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary.; Other Names: "pull-type" model, the Erlangen.
Active Comparator: Antegrade sphincterotomy. ASD.; 750 patients underwent a new antegrade sphincterotomy using the new sphincterotome design developed by Dr. Dovbenko (ASD). After deep bile duct cannulation, the new design of sphincterotome, antegradely cuts only circular muscle layer of the sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve cannulation new design sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.	Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.; Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla.; Other Names: ASD; Device: The antegrade sphincterotome developed by Dr. Dovbenko.; A device is represented by a teflon catheter in the distal part of which a double tube of variable shape is created. The proximal part of the ASD sphincterotome consists of a handle, and a metal wire is located inside the teflon catheter for connection to an electrosurgical unit. On the distal part, the teflon catheter is formed of a double tube length is 10 to 35 mm. The metal wire exits the catheter at a distance 10 to 35 mm from the tip and enters into the tip the second teflon tube. The distal part of the knife is formed shape a hook. A metal cutting wire is located between two tubes. Moving the handle the metal wire is shifted. Pushing the metal wire or approaching in the distal part the second tube sets the depth of cut. The incision is made by moving on guidewire in bile duct. The power settings vary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with the complete removal of stones from bile ducts.	Complete extraction of stones from the bile ducts is controlled by cholangiogram data.	During the procedure.
The number of participants with acute pancreatitis.	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.	Up to 12 hours after the procedure.
The number of participants with acute bleeding.	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.	From during the procedure to two days after the procedure.
The number of participants with perforation of duodenum.	Clinical manifestation of duodenal perforation after procedure, confirmed by CT or surgery.	From one to 3 days after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with restenosis.	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.	From 1 to 5 years after the procedure.

Collaborators and Investigators

• Sponsor: Military Medical Clinical Center of the Southern Region, Ukraine

Publications and helpful links

Helpful Links

• Endoscopic transpapillary antegrade sphincterotomy.
• Endoscopic papillosphincterotomy: a technique and its methodologies.
• Endoscopic correction of biliary duct obstructions of non-tumor origin
• Equipment for endoscopic external and internal drainage of the ducts of the liver, pancreas, abscess and cyst cavity and method of drainage
• Diathermic knife and method of endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2003
• Primary Completion (Anticipated): December 21, 2022
• Study Completion (Anticipated): December 21, 2022

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: endoscopic transpapillary antegrade sphincterotomy (ASD); antegrade sphincterotome; preservation of the function of the sph. of Oddi; avoid cholecystectomy
• Other Study ID Numbers: 0682539685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: the highly detailed IPD available in the original CRFs
• IPD Sharing Time Frame: 21/01/2021 within 3 months
• IPD Sharing Access Criteria: personal contact
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No