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IRCT20261012071401N1 IRCT 2026-10-16 Tabriz University of Medical Sciences Synergistic Effects of Cryoprevention and Rectal Diclofenac on the Prevention of Post-ERCP Pancreatiti CAD-PEP The Effect of Cryoprevention Combined with Rectal Diclofenac Suppository Versus Rectal Diclofenac Alone in the Prevention of Post-ERCP Pancreatitis 2026-03-21 anticipated 100 Recruiting https://irct.ir/trial/94029 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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. N/A Post-ERCP Pancreatitis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The Effect of Cryoprevention Combined with Rectal Diclofenac versus Rectal Diclofenac Alone in Preventing Post-ERCP Pancreatitis When: Access Period Start: 1406 (2027) To whom: Researchers and Physicians Conditions: Prevention of Post-ERCP Pancreatitis Where to obtain: dr.javad ghadimi / javadghh@gmail.com How to obtain: send email Comments:
public javad ghadimi
yaghchian
Tabriz Iran (Islamic Republic of) 5169637189 +98 41 3386 6074 javadghadimi@gmail.com Tabriz University of Medical Sciences scientific kasra khodadadi
tabriz valiasr
Tabriz Iran (Islamic Republic of) 5169637190 +98 41 3386 6074 khodadadikasra2020@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 K85.8 Other acute pancreatitis Prevention Prevention 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. 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. 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. Tabriz University of Medical Sciences Approved 2026-10-12 Ethics Committee of Tabriz University of Medical Sciences Deputy of Research and Technology, Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran tabriz East Azarbaijan Iran (Islamic Republic of)