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IRCT20220718055486N1 IRCT 2022-08-08 Tehran University of Medical Sciences Endoscopic necrosectomy for treatment of infected walled-off pancreatic necrosis Comparison of "immediate" endoscopic necrosectomy vs. "on-demand" necrosectomy for treatment of infected walled-off pancreatic necrosis 2022-08-23 anticipated 40 Complete https://irct.ir/trial/64833 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering the small sample size and in order to balance the number of patients in two study groups, participants of this study were randomly assigned to each group using the restricted randomization method of "permuted block randomization". This way, in this study the block size of 4 would be used so that in each block 2 patients is assigned to the case group and 2 to the control one; having filled each block, the filling process of next block would be started. Before beginning of the investigation, the order of 10 blocks and the order of intra-block case assignment are prepared by a blinded statistician using “Random Allocation Software”, and the assignment would be performed accordingly as follows. The sequential blocks are saved in the computer as ten folders (numbered 1 to 10) each containing four Word files (numbered 1 to 4) and either A (meaning “immediate” endoscopic necrosectomy) or B (meaning “on-demand” endoscopic necrosectomy) is written in each file. For the first patient, the folder No. 1 and then the containing Word file No. 1 are opened to determine the patient’s group (A or B). For the 2nd to 4th patients, the Word files No. 2 to No. 4 from folder 1 are sequentially opened. For the 5th to 8th patients, the Word files No. 1 to No. 4 from folder 2 are sequentially opened; and this way, the random allocation process is continued for the next patients, Blinding description: The physician who performs the interventions could not be blinded. The responsible physician for post-procedural care and the investigator who collects the data and evaluates the outcomes, however, would be blinded to the randomization assignment. N/A Acute pancreatitis; Infected walled off necrosis. Intervention 1: Intervention group ("immediate" necrosectomy): Patients at this group will have endoscopic necrosectomy at the time of stent placement. The necrotic collection is identified with endoscopic ultrasonography (EUS); then transmural placement of cystogastrostomy stent under EUS guidance is performed. The type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at the discretion of endoscopist. Immediately after stent placement, the track is dilated with a 15 mm through-the-scope (TTS) balloon; then, direct endoscopic necrosectomy is performed with CO2 insufflation for 45 to 90 minutes. Intervention 2: Control group ("immediate" necrosectomy): For patients in this group, endoscopic necrosectomy is not performed at the time of stent placement. Here again, the necrotic collection is identified with endoscopic ultrasonography (EUS); then transmural placement of cystogastrostomy stent under EUS guidance is performed. Again, the type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at the discretion of endoscopist. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated (e.g. no improvement in inflammatory markers, persistant multi-organ failure, or recurrence of these indices after a primary improvement). The necrosectomy procedure, if any, is performed with CO2 insufflation for 45 to 90 minutes. Yes - There is a plan to make this available What will be shared: All the individual patient data and codes used for study analysis would be shared online on request. All other data or documents of the study would also be released either as a published paper or its appendix, or as requested. When: Since 6 months after study results are published To whom: All who request Conditions: Any kind of use of the study data will only be allowed with the permission of the corresponding author of the published paper from the study. Where to obtain: Sending email to the corresponding author of the published paper from the study How to obtain: Sending an official email to the corresponding author and receiving his approval Comments:
public Morteza Hassanzadeh
Rasoul-e-Akram Medical Center, Niyayesh St., Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 1445613131 0098 21 64351 drmhxim@gmail.com Iran University of Medical Sciences scientific Mehdi Mohamadnejad
Digestive Disease Research Institute (DDRI), Shariati Hospital, Intersection of north Karegar street and Jalal-E-Al-E-Ahmad highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8241 5000 mehdi.nejad@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of walled-off pancreatic necrosis At least 20% solid component at the necrotic lesion 18 years no limit Both Uncorrectable coagulopathy with platelet count < 50,000 or INR > 1.5 Location of the infected walled-off pancreatic necrosis is unreachable with endosonography Pregnancy (in females) Prior intervention on the infected walled-off pancreatic necrosis (such as cutaneous drainage, ...) K85.9 Acute pancreatitis, unspecified Treatment - Other Treatment - Other Intervention group ("immediate" necrosectomy): Patients at this group will have endoscopic necrosectomy at the time of stent placement. The necrotic collection is identified with endoscopic ultrasonography (EUS); then transmural placement of cystogastrostomy stent under EUS guidance is performed. The type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at the discretion of endoscopist. Immediately after stent placement, the track is dilated with a 15 mm through-the-scope (TTS) balloon; then, direct endoscopic necrosectomy is performed with CO2 insufflation for 45 to 90 minutes. Control group ("immediate" necrosectomy): For patients in this group, endoscopic necrosectomy is not performed at the time of stent placement. Here again, the necrotic collection is identified with endoscopic ultrasonography (EUS); then transmural placement of cystogastrostomy stent under EUS guidance is performed. Again, the type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at the discretion of endoscopist. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated (e.g. no improvement in inflammatory markers, persistant multi-organ failure, or recurrence of these indices after a primary improvement). The necrosectomy procedure, if any, is performed with CO2 insufflation for 45 to 90 minutes. Size of infected walled-off pancreatic necrosis. Timepoint: 1 month and 3 months. Method of measurement: Abdominal computerized tomography (CT) scan. Clinical symptoms and signs related to the infected walled off pancreatic necrosis. Timepoint: 1 months and 3 months. Method of measurement: Patient interview. Complications after endoscopic necrosectomy. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Clinical evaluation and reviewing the patient's medical records. Length-of-stay in hospital. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records. Number of necrosectomy sessions. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records. Mean time of necrosectomies. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records. Survival after 3 months. Timepoint: 3 months after stent placement. Method of measurement: Interview with the patient or his/her relatives. Rate of newly-diagnosed diabetes. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Laboratory evaluation (blood glucose). Tehran University of Medical Sciences Approved 2022-05-17 Ethics committee of Digestive Disease Research Institute (DDRI), Tehran University of Medical Scienc Digestive Diseases Research Institute (DDRI), Shariati Hospital, North Kargar Street Tehran Tehran Iran (Islamic Republic of)