CholedocholithiasisASDNCT04406961
Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy
A study testing Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., The antegrade sphincterotome developed by Dr. Dovbenko. and Endoscopic sphincterotomy. in people with Choledocholithiasis and Papillary Stenosis, run by Military Medical Clinical Center of the Southern Region, Ukraine at 1 site in Ukraine.
Trial summary
This study compares endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD) with conventional pull-type endoscopic sphincterotomy (EST) in patients undergoing transpapillary interventions for various indications, including biliary stone disease, major… Read more about this study
- Who is it for?
- Ages 18 to 102 years
- Conditions the study is for
- Choledocholithiasis, Papillary Stenosis, Biliary Obstruction
- What is being tested?
- Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., The antegrade sphincterotome developed by Dr. Dovbenko. and Endoscopic sphincterotomy.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,521 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jan 2020to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 102 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Antegrade Sphincterotomy Dovbenko (ASD) With Conventional Pull-Type Sphincterotomy in Patients Undergoing ERCP
This study compares endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD) with conventional pull-type endoscopic sphincterotomy (EST) in patients undergoing transpapillary interventions for various indications, including biliary stone disease, major duodenal papilla stenosis, choledocholithiasis, and other conditions requiring access to the biliary and/or pancreatic ducts. The ASD technique is performed using a dedicated sphincterotome designed by Dr. Dovbenko. Both the technique and the device are patented in Ukraine (Patent No. UA 117987C2, 2019). This instrument enables selective incision of only the circular muscle layer of the sphincter of Oddi, thereby preserving its sphincteric function and minimizing trauma to the duodenal wall. The primary objective of the study is to evaluate the relative risk of procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and the need for cholecystectomy.
Read the detailed description
Anatomical studies confirm that the sphincter of Oddi comprises an inner circular muscle layer, functionally and structurally distinct from the duodenum, and an outer longitudinal layer derived from the duodenal wall. Preservation of this architecture is critical to maintaining sphincteric function. Standard pull-type sphincterotomy frequently disrupts both layers and adjacent duodenal tissue, contributing to procedure-related complications in up to 23% of ERCPs, including bleeding (≤3%), perforation (≤1%), and post-sphincterotomy reflux complications.
Antegrade Sphincterotomy Dovbenko (ASD) was developed to address these limitations. Using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019), ASD enables selective incision of the circular layer while sparing the longitudinal layer and duodenal integrity.
This prospective, randomized, parallel-group trial (NCT04406961) enrolled 1,521 patients requiring transpapillary intervention for biliary or pancreatic indications. Patients were assigned to ASD (n=761) or conventional EST (n=760).
In the ASD group, a trend toward reduced major complications was observed (RR 0.55; 95% CI 0.18-1.67); however, this difference did not reach statistical significance, likely due to the low absolute number of events. Notably, cholecystectomy was avoided in 71.2% of ASD patients with gallstone disease, compared to approximately 10% in the EST group. Temporary stenting (5-10 days) was used selectively to manage post-procedural edema. ASD should be performed exclusively by endoscopists with advanced transpapillary expertise.
- Conditions
- Choledocholithiasis, Papillary Stenosis, Biliary Obstruction, Gallstone Disease, External Biliary Fistula, Malignant Biliary Obstruction
- Being tested
- Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., The antegrade sphincterotome developed by Dr. Dovbenko., Endoscopic sphincterotomy., The standard sphincterotome.
- Keywords
- endoscopic transpapillary antegrade sphincterotomy (ASD), antegrade sphincterotome, preservation of the function of the sph. of Oddi, avoid cholecystectomy
- Medical subject headings
- Choledocholithiasis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.Procedure or surgery
Also called ASD
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.
The antegrade sphincterotome developed by Dr. Dovbenko.Device
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.
Endoscopic sphincterotomy.Procedure or surgery
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.
The standard sphincterotome.Device
Also called "pull-type" model, the Erlangen.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard sphincterotomy. | Active comparator | Patients in this group underwent conventional retrograde endoscopic sphincterotomy using a standard Erlangen-type "pull" sphincterotome. Following deep biliary cannulation, the sphincterotome was used to perform a standard pull-type incision across the major duodenal papilla. In 20% of cases, a needle-knife precut papillotomy was performed to facilitate biliary access. A total of 760 patients were enrolled in this arm. Procedure-related complications were prospectively recorded, including: post-ERCP pancreatitis, bleeding, perforation, cholangitis, acute cholecystitis, recurrent choledocholithiasis, and papillary restenosis. Receives: Procedure: Endoscopic sphincterotomy.; Device: The standard sphincterotome. |
| Antegrade Sphincterotomy Dovbenko (ASD) | Experimental | Patients underwent endoscopic transpapillary antegrade sphincterotomy (Antegrade Sphincterotomy Dovbenko, ASD) using a dedicated sphincterotome designed by Dr. Dovbenko (Ukrainian Patent No. UA 117987C2, 2019). Following deep biliary cannulation, the sphincterotome was advanced transpapillary and used to perform an antegrade incision selectively targeting only the circular muscle layer of the sphincter of Oddi, with preservation of the longitudinal layer and duodenal integrity. In 20% of cases, needle-knife precut papillotomy was performed to facilitate initial biliary cannulation. Receives: Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.; Device: The antegrade sphincterotome developed by Dr. Dovbenko. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of major procedure-related adverse events
Proportion of participants experiencing at least one of the following within 30 days: (1) post-ERCP pancreatitis (serum lipase ≥3× upper limit of normal plus abdominal pain persisting ≥24 hours requiring prolonged or unplanned hospitalization); (2) clinically significant bleeding (hemoglobin drop ≥2 g/dL and/or need for endoscopic, radiological, or surgical intervention); (3) duodenal or biliary perforation confirmed by imaging or surgery.
Measured: Up to 30 days after the procedure.
Secondary outcomes (7)
Incidence of papillary restenosis requiring re-intervention
Papillary restenosis is defined as recurrent biliary obstruction confirmed by imaging (CT, MRI, or cholangiography), characterized by:
- common bile duct diameter >11 mm, and
- total bilirubin >60 µmol/L (≈3.5 mg/dL) in the absence of other causes of obstruction.
Only cases requiring endoscopic, radiological, or surgical re-intervention are counted as events.
Measured: From 6 months to 5 years after the procedure
Incidence of post-ERCP pancreatitis.
Post-ERCP pancreatitis is defined as new-onset abdominal pain persisting for at least 24 hours plus serum lipase level at least 3 times the upper limit of normal, requiring prolonged or unplanned hospitalization for pain management and monitoring.
Measured: Within 72 hours after the procedure
Incidence of duodenal or biliary perforation.
Perforation is defined as a full-thickness defect of the duodenal or bile duct wall, confirmed by: (1) extraluminal contrast on cholangiography or fluoroscopy, (2) free air on abdominal X-ray or CT scan, or (3) intraoperative diagnosis. Perforations are classified as periampullary, duodenal, or biliary.
Measured: From the start of the procedure up to 30 days after.
Incidence of clinically significant post-sphincterotomy bleeding
Clinically significant bleeding is defined as: (1) a decrease in hemoglobin level of ≥2 g/dL from pre-procedure baseline, and/or (2) requirement for endoscopic, radiological, or surgical intervention to achieve hemostasis. Minor oozing not requiring intervention is not counted as an event.
Measured: From the start of the procedure up to 30 days after
Rate of cholecystectomy within 12 months
Proportion of participants with concomitant gallstone disease who undergo cholecystectomy within 12 months following the index ERCP procedure, regardless of symptoms. Only elective or urgent cholecystectomies performed for biliary pathology are included; procedures for unrelated indications are excluded.
Measured: From the date of the procedure up to 12 months
Technical success: complete bile duct stone clearance
Defined as the absence of residual filling defects in the common bile duct on post-procedure cholangiography (intraoperative or fluoroscopic). Clearance is confirmed before the end of the index ERCP session.
Measured: During the procedure
Need for repeat ERCP within 30 days
Proportion of participants requiring a repeat endoscopic retrograde cholangiopancreatography (ERCP) within 30 days after the index procedure due to: (1) incomplete stone clearance, (2) recurrent biliary obstruction, (3) post-procedure complications (e.g., cholangitis, bleeding, or stent dysfunction), or (4) other biliary or pancreatic indications directly related to the initial intervention.
Elective ERCP for unrelated reasons is excluded.
Measured: From the date of the index procedure up to 30 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2020
- Primary completion21 Dec 2024
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This parallel-group, randomized controlled trial compares two endoscopic sphincterotomy techniques in patients undergoing transpapillary interventions: (1) conventional pull-type endoscopic sphincterotomy (EST), and (2) antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD), which selectively incises only the circular muscle layer of the sphincter of Oddi using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019). The primary analysis evaluates the relative risk and 95% confidence interval for procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and need for cholecystectomy.
- Masking
- None (open label)
- Enrolment
- 1,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Medical Clinical Center of the Southern Region, Ukraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleg Dovbenko, MD, Military Medical Clinical Center of the Southern Region, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406961
- Sponsor's protocol ID
- Protocol-273
- Other IDs
- 273
- Acronym
- ASD
- Status last verified
- Jan 2026
- First submitted
- 2 May 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) collected during the trial, including de-identified baseline characteristics, procedural details, outcomes, and adverse events, will be available.
Publications
Dovbenko O, Herasymenko O. Endoscopic management of hepaticojejunal anastomosis fistula after Whipple's resection. Endoscopy. 2024 Dec;56(S 01):E72-E73. doi: 10.1055/a-2226-0276. Epub 2024 Jan 23. No abstract available.
PubMed 38262462
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Antegrade Sphincterotomy Dovbenko (ASD) With Conventional Pull-Type Sphincterotomy in Patients Undergoing ERCP
- ClinicalTrials.gov ID
- NCT04406961
- Acronym / sponsor ID
- ASD / Protocol-273
- Conditions
- Choledocholithiasis, Papillary Stenosis, Biliary Obstruction, Gallstone Disease, External Biliary Fistula, Malignant Biliary Obstruction
- Keywords
- endoscopic transpapillary antegrade sphincterotomy (ASD), antegrade sphincterotome, preservation of the function of the sph. of Oddi, avoid cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,521 participants (actual)
- Lead sponsor
- Military Medical Clinical Center of the Southern Region, UkraineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD) with conventional pull-type endoscopic sphincterotomy (EST) in patients undergoing transpapillary interventions for various indications, including biliary stone disease, major duodenal papilla stenosis, choledocholithiasis, and other conditions requiring access to the biliary and/or pancreatic ducts. The ASD technique is performed using a dedicated sphincterotome designed by Dr. Dovbenko. Both the technique and the device are patented in Ukraine (Patent No. UA 117987C2, 2019). This instrument enables selective incision of only the circular muscle layer of the sphincter of Oddi, thereby preserving its sphincteric function and minimizing trauma to the duodenal wall. The primary objective of the study is to evaluate the relative risk of procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and the need for cholecystectomy.
Detailed description
Anatomical studies confirm that the sphincter of Oddi comprises an inner circular muscle layer, functionally and structurally distinct from the duodenum, and an outer longitudinal layer derived from the duodenal wall. Preservation of this architecture is critical to maintaining sphincteric function. Standard pull-type sphincterotomy frequently disrupts both layers and adjacent duodenal tissue, contributing to procedure-related complications in up to 23% of ERCPs, including bleeding (≤3%), perforation (≤1%), and post-sphincterotomy reflux complications.
Antegrade Sphincterotomy Dovbenko (ASD) was developed to address these limitations. Using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019), ASD enables selective incision of the circular layer while sparing the longitudinal layer and duodenal integrity.
This prospective, randomized, parallel-group trial (NCT04406961) enrolled 1,521 patients requiring transpapillary intervention for biliary or pancreatic indications. Patients were assigned to ASD (n=761) or conventional EST (n=760).
In the ASD group, a trend toward reduced major complications was observed (RR 0.55; 95% CI 0.18-1.67); however, this difference did not reach statistical significance, likely due to the low absolute number of events. Notably, cholecystectomy was avoided in 71.2% of ASD patients with gallstone disease, compared to approximately 10% in the EST group. Temporary stenting (5-10 days) was used selectively to manage post-procedural edema. ASD should be performed exclusively by endoscopists with advanced transpapillary expertise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This parallel-group, randomized controlled trial compares two endoscopic sphincterotomy techniques in patients undergoing transpapillary interventions: (1) conventional pull-type endoscopic sphincterotomy (EST), and (2) antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD), which selectively incises only the circular muscle layer of the sphincter of Oddi using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019). The primary analysis evaluates the relative risk and 95% confidence interval for procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and need for cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| Standard sphincterotomy. | Active comparator | Procedure: Endoscopic sphincterotomy., Device: The standard sphincterotome.Patients in this group underwent conventional retrograde endoscopic sphincterotomy using a standard Erlangen-type "pull" sphincterotome. Following deep biliary cannulation, the sphincterotome was used to perform a standard pull-type incision across the major duodenal papilla. In 20% of cases, a needle-knife precut papillotomy was performed to facilitate biliary access. A total of 760 patients were enrolled in this arm. Procedure-related complications were prospectively recorded, including: post-ERCP pancreatitis, bleeding, perforation, cholangitis, acute cholecystitis, recurrent choledocholithiasis, and papillary restenosis. |
| Antegrade Sphincterotomy Dovbenko (ASD) | Experimental | Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., Device: The antegrade sphincterotome developed by Dr. Dovbenko.Patients underwent endoscopic transpapillary antegrade sphincterotomy (Antegrade Sphincterotomy Dovbenko, ASD) using a dedicated sphincterotome designed by Dr. Dovbenko (Ukrainian Patent No. UA 117987C2, 2019). Following deep biliary cannulation, the sphincterotome was advanced transpapillary and used to perform an antegrade incision selectively targeting only the circular muscle layer of the sphincter of Oddi, with preservation of the longitudinal layer and duodenal integrity. In 20% of cases, needle-knife precut papillotomy was performed to facilitate initial biliary cannulation. |
Who may qualify
- Ages
- 18 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.Also: ASDSph. 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. | Procedure or surgery | Antegrade Sphincterotomy Dovbenko (ASD) |
| 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. | Device | Antegrade Sphincterotomy Dovbenko (ASD) |
| 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. | Procedure or surgery | Standard sphincterotomy. |
| The standard sphincterotome.Also: "pull-type" model, the Erlangen.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. | Device | Standard sphincterotomy. |
Primary outcome
Composite incidence of major procedure-related adverse events
Time frame: Up to 30 days after the procedure.
Proportion of participants experiencing at least one of the following within 30 days: (1) post-ERCP pancreatitis (serum lipase ≥3× upper limit of normal plus abdominal pain persisting ≥24 hours requiring prolonged or unplanned hospitalization); (2) clinically significant bleeding (hemoglobin drop ≥2 g/dL and/or need for endoscopic, radiological, or surgical intervention); (3) duodenal or biliary perforation confirmed by imaging or surgery.
7 secondary outcomes
Incidence of papillary restenosis requiring re-intervention
Time frame: From 6 months to 5 years after the procedure
Incidence of post-ERCP pancreatitis.
Time frame: Within 72 hours after the procedure
Incidence of duodenal or biliary perforation.
Time frame: From the start of the procedure up to 30 days after.
Incidence of clinically significant post-sphincterotomy bleeding
Time frame: From the start of the procedure up to 30 days after
Rate of cholecystectomy within 12 months
Time frame: From the date of the procedure up to 12 months
Technical success: complete bile duct stone clearance
Time frame: During the procedure
Need for repeat ERCP within 30 days
Time frame: From the date of the index procedure up to 30 days after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 38262462Dovbenko O, Herasymenko O. Endoscopic management of hepaticojejunal anastomosis fistula after Whipple's resection. Endoscopy. 2024 Dec;56(S 01):E72-E73. doi: 10.1055/a-2226-0276. Epub 2024 Jan 23. No abstract available.
- Endoscopic transpapillary antegrade sphincterotomy (ASD): preliminary results. Endoscopy 2019;51(S 04):S192. Abstract presented at ESGE Days 2019, Prague.Link provided by the sponsor.
- Diathermic knife and method of endoscopic transpapillary antegrade sphincterotomy developed by Dr. O.V. Dovbenko. Ukrainian Patent UA117987C2, issued 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) collected during the trial, including de-identified baseline characteristics, procedural details, outcomes, and adverse events, will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., The antegrade sphincterotome developed by Dr. Dovbenko. and Endoscopic sphincterotomy. in people with Choledocholithiasis and Papillary Stenosis, run by Military Medical Clinical Center of the Southern Region, Ukraine at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of major procedure-related adverse events (time frame: Up to 30 days after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.