The main objective of this study is to investigate the synergistic effect of cryoprevention combined with rectal diclofenac suppository versus rectal diclofenac alone in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis
Design
Randomized controlled trial with parallel groups, involving blinding of the patient, outcome assessor, and statistician on one hundred patients
Settings and conduct
This study is conducted at Imam Reza Hospital, affiliated with Tabriz University of Medical Sciences. Eligible patients are randomly allocated into an intervention group receiving cold water infusion with rectal diclofenac and a control group receiving rectal diclofenac alone. This study is performed as a triple-blind trial involving blinding of the patient, outcome assessor, and statistician.
Participants/Inclusion and exclusion criteria
nclusion Criteria:
- Age ≥18 years
- Native papilla
- No NSAID contraindications
- Written informed consent
Exclusion Criteria:
- Need for prophylactic pancreatic stenting
- Failed ERCP
- Pre-existing pancreatitis
- Pancreatic cancer or cholangiocarcinoma
- Acute or chronic pancreatitis
Intervention groups
ntervention Group: After successful cannulation, 250 mL of 4°C cold water is infused into the papilla, and 100 mg rectal diclofenac is administered before ERCP.
Control Group: Patients receive 100 mg rectal diclofenac before ERCP, without cold water infusion.
Main outcome variables
The occurrence of pancreatitis is evaluated based on clinical criteria and abdominal symptoms. Furthermore, the magnitude of changes and elevation in serum levels of amylase and lipase enzymes are measured and assessed twenty-four hours after the procedure.
General information
Reason for update
Acronym
CAD-PEP
IRCT registration information
IRCT registration number:IRCT20261012071401N1
Registration date:2026-10-16, 1405/07/24
Registration timing:registered_while_recruiting
Last update:2026-10-16, 1405/07/24
Update count:0
Registration date
2026-10-16, 1405/07/24
Registrant information
Name
javad Ghadimi haji agha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 6543
Email address
javadghh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-21, 1405/01/01
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cryoprevention Combined with Rectal Diclofenac Suppository Versus Rectal Diclofenac Alone in the Prevention of Post-ERCP Pancreatitis
Public title
Synergistic Effects of Cryoprevention and Rectal Diclofenac on the Prevention of Post-ERCP Pancreatiti
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a native papilla (no history of prior manipulation)
Absence of contraindications to NSAID use (active peptic ulcer disease, GFR<30 mL/min/1.73m2GFR<30 mL/min/1.73m2, known hypersensitivity to NSAIDs, or recent gastrointestinal bleeding)
Written informed consent for participation in the study
Exclusion criteria:
Requirement for prophylactic pancreatic stent placement
Unsuccessful ERCP procedure
Pre-existing pancreatitis prior to ERCP
Patients diagnosed with pancreatic cancer or cholangiocarcinoma
Patients with acute or chronic pancreatitis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Given the nature of the intervention under investigation—namely, papillary irrigation with cold water during ERCP—blinding of the performing endoscopist is not feasible. However, to minimize potential bias, blinding will be implemented for the patients, outcome assessor, and statistical analyst.
Patients will remain blinded to their assigned group due to undergoing the procedure under sedation and lacking awareness of the procedural details during ERCP. Furthermore, information regarding the treatment allocation will not be disclosed to the patient after the procedure.
The primary outcome of the study—the incidence of post-ERCP pancreatitis (PEP)—will be evaluated by an independent individual who has no role in the procedure or group allocation and is blinded to the intervention type. The diagnosis of PEP will be established based on predefined clinical and laboratory criteria.
To maintain blinding of the statistical analysis, the study groups will be recorded in the data file as codes A and B, and the statistician will remain unaware of the intervention nature of each group until the completion of the analysis. Unblinding will be performed only after the final analysis is completed.
Therefore, this study will be conducted as a randomized controlled trial with blinded patients, a blinded outcome assessor, and a blinded statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Deputy of Research and Technology, Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۱۱
Approval date
2026-10-12, 1405/07/20
Ethics committee reference number
IR.TBZMED.REC.1405.499
Health conditions studied
1
Description of health condition studied
Post-ERCP Pancreatitis
ICD-10 code
K85.8
ICD-10 code description
Other acute pancreatitis
Primary outcomes
1
Description
Incidence of post-ERCP pancreatitis (defined as new-onset upper abdominal pain characteristic of pancreatitis accompanied by an increase in serum amylase or lipase to at least 3 times the upper limit of normal within 24 hours after the procedure)
Timepoint
Measurement of serum amylase and lipase levels and clinical evaluation for typical abdominal pain symptoms at baseline (prior to the ERCP procedure), and subsequently at 24 hours post-ERCP procedure
Method of measurement
Measurement of serum amylase and lipase levels via venous blood sampling using standard laboratory kits and an automated clinical chemistry analyzer, combined with thorough clinical examination by a physician to assess typical abdominal pain consistent with standard diagnostic criteria for acute pancreatitis
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in this group receive only the standard care for the prevention of post-procedural pancreatitis. Specifically, prior to the endoscopic retrograde cholangiopancreatography procedure, a 100 mg diclofenac sodium suppository (manufactured by a reputable domestic pharmaceutical company) is administered rectally to the patient. No cryoprevention intervention or local cold-water irrigation will be performed for this group, and subsequent care will be provided according to the standard ward protocol.
Category
Prevention
2
Description
Intervention group: Patients in this group receive a combined intervention. Prior to the endoscopic retrograde cholangiopancreatography procedure, a 100 mg diclofenac sodium suppository (manufactured by a reputable domestic pharmaceutical company) is administered rectally to the patient. Furthermore, following successful biliary cannulation and at the end of the procedure, a cryoprevention intervention (local cold therapy of the papillary region) is performed; specifically, 250 cc of cold water (at a standard temperature of 4 degrees Celsius) is locally and controllably infused/irrigated through the scope into the ampulla of Vater and the surrounding papillary area to exert a cooling and anti-inflammatory effect. Subsequent care is continued according to the standard ward protocol.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
emam reza hospital
Full name of responsible person
جواد قدیمی
Street address
Imam Reza Hospital, adjacent to Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5169637187
Phone
+98 41 3334 7054
Email
emamrezahospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
دکتر خسرو ادیب کیا
Street address
Deputy of Research and Technology, 3rd Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5169637188
Phone
+98 41 3335 7310
Email
adibkia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
javad ghadimi
Position
Fellow in Adult Gastroenterology and Hepatology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
yaghchian
City
Tabriz
Province
East Azarbaijan
Postal code
5169637189
Phone
+98 41 3386 6074
Email
javadghadimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
kasra khodadadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
tabriz valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5169637190
Phone
+98 41 3386 6074
Email
khodadadikasra2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mohammad hosein somi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5169637191
Phone
+98 41 3386 6074
Email
somimh@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The Effect of Cryoprevention Combined with Rectal Diclofenac versus Rectal Diclofenac Alone in Preventing Post-ERCP Pancreatitis
When the data will become available and for how long
Access Period Start: 1406 (2027)
To whom data/document is available
Researchers and Physicians
Under which criteria data/document could be used
Prevention of Post-ERCP Pancreatitis
From where data/document is obtainable
dr.javad ghadimi / javadghh@gmail.com
What processes are involved for a request to access data/document