Effect of rectal diclofenac on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio_ Pancreatography) in comparison with control group

Effect of rectal diclofenac on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio_ Pancreatography) in comparison with control group

Clinical trial with intervention and control groups, double blind, randomized, phase three. Randomization: Random block A, B. Randomization Unit: Individual. Randomization tool: random number table. The operating physician, assistant and patient will not be aware of content of block. Sample size: 75 patients in control group and 75 patients in intervention group.

Participants will be randomly divided into two groups of patients and controls. The operating physician, assistant, and patient will not be aware of content of blocks (double blind). Randomly block A, B, individual randomization unit, table randomization tool. The endoscopy unit of Firoozgar Hospital will be located in Tehran.

Inclusion criteria: Age over 18 years ; Ability to sign consent ; Intact papillae ; No contraindication for diclofenac ; Having an ERCP indication ; Non-inclusion: Sphincterotomy ; Acute pancreatitis ; Basic amylase above 200 ; Allergy to diclofenac ;

All patients receive diclofenac suppository before operation.group A(intervention) received diclofenac suppository after ERCP too.

Acute pancreatitis after ERCP

Patients will be randomly assigned to two groups of 75 controls and treatment group. Random allocation of patients will be done using random block method with permutations BA, BA, AB, AB, AA, BB, AB, BA, BA, AB, BB, AA. Thus, for group A, patients will receive diclofenac suppositories immediately before and after ERCP, and for group B, diclofenac suppositories will be given just before ERCP. Participant blinding and outcome assessment will be done single-blind. Since the intervention is performed in patients during anesthesia and patients are blinded in this regard, the study will be conducted blindly due to the lack of placebo. Participants and outcome assessors are not aware of grouping. The patient is explained that he or she may be randomly assigned to groups A and group B. Randomization unit: individual (individuals are assigned to treatment groups) Randomization tool: Random blocking

After obtaining the patient's consent, the patient is explained that he / she may accidentally receive diclofenac suppository before and after ERCP in group A and diclofenac suppository before ERCP in group B. Participant blinding and outcome assessment will be done single-blind. Since the intervention is performed on patients during anesthesia, patients will be blinded in this regard, and the study will be conducted blindly due to the lack of placebo. Participants and outcome assessors are not aware of grouping. The patient is explained that he or she may be randomly assigned to groups A and group B. The patient will only be informed of the suppository before performing the ERCP, and after performing the ERCP, the patient will not be informed of whether or not to prescribe the suppository. Only the operating room nurse who distributes the NSAID suppository is aware of the patient's presence in the intervention or control group that they are not involved in the research and will perform the random assignment operation.