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Comparison between Precut Needle Knife Sphincterotomy and Precut Pancreatic Sphincterotomy in Management of Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography.

Comparison between Precut Needle Knife Sphincterotomy and Precut Pancreatic Sphincterotomy in Management of Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: A Randomised Control Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150224003
Enrollment
80
Registered
2015-02-24
Start date
2012-06-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult cannulation of ampulla of Vater during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure ERCP&#45

Interventions

Precut Needle Knife Sphincterotomy is a procedure for coping with difficult cannulation
this procedure uses needle knife to cut ampulla of Vater to identify opening of bile duct for deep cannulation into the bile duct.,Precut Pancreatic Sphincterotomy is a procedure for dealing with diff
this procedure uses traction type papillotome to cut the septum between pancreatic duct and distal bile duct in ampulla of Vater to gain access for deep cannulation to bile duct.
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Precut Needle Knife Sphincterotomy,Precut Pancreatic Sphincterotomy

Sponsors

Khon Kaen Hospital
Lead Sponsor
Department of Surgery&#44
Collaborator
Khon Kaen Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who was performed ERCP with: 1. Failure to perform successful cannulation within 10 minutes after ampulla of Vater was found. 2. Cannulation to pancreatic duct more than 3 times. 3. Injection of contrast media to pancreatic duct more than3 times.

Exclusion criteria

Exclusion criteria: 1. Patients who did not agree to join the clinical trial 2. Age below 15 3. Pregnant patients 4. Patients with cholangitis 5. Patients with pancreatitis

Design outcomes

Primary

MeasureTime frame
Successful cannulation rate At the end of the procedure Percent

Secondary

MeasureTime frame
Procedural related complication 30 days after ERCP Percent

Countries

Thailand

Contacts

Public ContactSurachai Siripornadulsilp

Khon Kaen Hospital

sura_chai31@hotmail.com043336789

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026