Investigating the efficacy and safety of two fistulotomy techniques with the primary needle knife compared to the standard technique in patients undergoing ERCP with long papillae
Design
Clinical trial with parallel groups, single blind, randomized, sample size 181
patients, Excel software was used for randomization.
Settings and conduct
In the endoscopy department of Taleghani Hospital, patients with indications for ERCP with large papilla are randomly divided into two groups with a blinding strain. Patients are blinded to the type of intervention and the researcher in the study. For the first group, bile duct cannulation will be done with the basic needle knife method. For the second group, patients undergo cannulation with a standard method. After the procedure, the success rate of each of the methods as well as the rate of complications after that will be evaluated.
Participants/Inclusion and exclusion criteria
Patients suspected of acute biliary pancreatitis, biochemical findings and ultrasound findings Exclusion conditions: cardiopulmonary disease and other systemic diseases that endanger anesthesia
Intervention groups
Candidates for ERCP with large papillae are randomly divided into two groups. The first group of bile duct cannulation with the basic needle knife method and the second group of patients are subjected to cannulation with the standard method.
Main outcome variables
cannulation success rate; Complications include pancreatitis, perforation, bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056313N1
Registration date:2023-07-24, 1402/05/02
Registration timing:prospective
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
mehrnoosh alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
mehrnoosh_alizadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla: A single blind randomized prospective study
Public title
Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
Patients with acute pancreatitis
Patients with gallstones
ultrasound findings (CBD dilatation) that indicate CBD stone and CBD obstruction.
Exclusion criteria:
Age less than 18 years
pregnancy
Contrast sensitivity
History of previous sphincterectomy
Refusal to give informed written consent
Gastrojejunostomy
Patients with severe coagulopathy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
181
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups using the random block method. The number of blocks will be 4 and in each block three patients will be included in the study order. Random allocation of blocks of patients to two treatment groups will be done through Sealed Envelope online software. The randomized list of blocks is placed in sealed envelopes and will be provided to the endoscopist on a daily basis
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be done in a blind way. The evaluator does not know how to assign patients to the group in order to prevent misuse in measuring the results of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Visual diagnosis of the endoscopist by observing the cannulation process on the monitor
2
Description
post ERCP complication
Timepoint
During or after the procedure
Method of measurement
Clinical evidence and laboratory tests of bleeding, perforation, pancreatitis
Secondary outcomes
1
Description
Body temperature
Timepoint
4 hours after the completion of the procedure
Method of measurement
thermometer
2
Description
amylas
Timepoint
before the procedure and 3 hours after the procedure
Method of measurement
blood test for investigation of Amylas level
3
Description
lipas
Timepoint
before the procedure and 3 hours after the procedure
Method of measurement
blood test for investigation of lipas level
Intervention groups
1
Description
Intervention group: Intervention group: In the first group, the bile ducts of the patients will be cannulated with a standard technique. In this technique, the guidewire enters the bile duct through the papilla. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes, depending on the difficulty of cannulation.
Category
Other
2
Description
Intervention group: In the second group, entry into the bile duct will be done with the basic needle-knife technique. In this technique, first an incision is made above the papilla hole, and then the guidewire will enter the bile duct through this incision. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation.