Comparing the success rate of “immediate” vs. “on demand” endoscopic necrosectomy for infected walled off pancreatic necrosis (WOPN)
Design
Two arm, parallel group, single blind randomized clinical trial (randomization with using "random number table")
Settings and conduct
Patients with infected walled off pancreatic necrosis, admitted to the Shariati Hospital, Tehran, Iran, are randomly assigned to study groups. Patients at both groups would be followed up for 3 months and compared in terms of success rate and complications. The responsible physician for postprocedure care and the outcome assessors would be blinded to the random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age at least 18 years
2. Definite diagnosis of infected walled off pancreatic necrosis
3. At least 20% solid component at the necrotic lesion
Exclusion criteria:
1. Uncorrectable coagulopathy with platelet count less than 50,000 or international normalized ratio (INR) above 1.5
2. Location of the infected walled-off pancreatic necrosis is unreachable with endosonography
3. Pregnancy (in females)
4. Prior intervention on the infected walled-off pancreatic necrosis (such as cutaneous drainage, ...)
Intervention groups
"Immediate" necrosectomy group: Patients at this group will have endoscopic necrosectomy at the time of stent placement.
"On demand" necrosectomy group: For patients in this group, endoscopic necrosectomy is not performed at the time of stent placement. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated.
Main outcome variables
Clinical success rate; Complication rate; Duration of hospitalization; Number of necrosectomy sessions; Mean time of necrosectomies; Size of walled off pancreatic necrosis after 1 and 3 months; Survival after 3 months; Incidence rate of new diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220718055486N1
Registration date:2022-08-08, 1401/05/17
Registration timing:prospective
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
Morteza Hassanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3411
Email address
hassanzadeh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "immediate" endoscopic necrosectomy vs. "on-demand" necrosectomy for treatment of infected walled-off pancreatic necrosis
Public title
Endoscopic necrosectomy for treatment of infected walled-off pancreatic necrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of walled-off pancreatic necrosis
At least 20% solid component at the necrotic lesion
Exclusion criteria:
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, ...)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Digestive Disease Research Institute (DDRI), Tehran University of Medical Scienc
Street address
Digestive Diseases Research Institute (DDRI), Shariati Hospital, North Kargar Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۵
Approval date
2022-05-17, 1401/02/27
Ethics committee reference number
IR.TUMS.DDRI.REC.1401.008
Health conditions studied
1
Description of health condition studied
Acute pancreatitis; Infected walled off necrosis
ICD-10 code
K85.9
ICD-10 code description
Acute pancreatitis, unspecified
Primary outcomes
1
Description
Size of infected walled-off pancreatic necrosis
Timepoint
1 month and 3 months
Method of measurement
Abdominal computerized tomography (CT) scan
2
Description
Clinical symptoms and signs related to the infected walled off pancreatic necrosis
Timepoint
1 months and 3 months
Method of measurement
Patient interview
Secondary outcomes
1
Description
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
2
Description
Length-of-stay in hospital
Timepoint
1 month and 3 months after stent placement
Method of measurement
Reviewing the patient's medical records
3
Description
Number of necrosectomy sessions
Timepoint
1 month and 3 months after stent placement
Method of measurement
Reviewing the patient's medical records
4
Description
Mean time of necrosectomies
Timepoint
1 month and 3 months after stent placement
Method of measurement
Reviewing the patient's medical records
5
Description
Survival after 3 months
Timepoint
3 months after stent placement
Method of measurement
Interview with the patient or his/her relatives
6
Description
Rate of newly-diagnosed diabetes
Timepoint
1 month and 3 months after stent placement
Method of measurement
Laboratory evaluation (blood glucose)
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Morteza Hassanzadeh
Street address
Digestive Disease Research Institute (DDRI), Shariati Hospital, Intersection of North Karegar street and Jalal-E-Al-E-Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
drmhxim@gmail.com
Web page address
https://www.ddri.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Research and Technology Vice-Chancellor, Central building of Tehran University of Medical Sciences, Intersection of Ghods street and Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Iran University of Medical Sciences
Full name of responsible person
Morteza Hassanzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasoul-e-Akram Medical Center, Niyayesh St., Sattarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Fax
+98 21 8670 3411
Email
drmhxim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Mohamadnejad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and hepatology
Street address
Digestive Disease Research Institute (DDRI), Shariati Hospital, Intersection of north Karegar street and Jalal-E-Al-E-Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
mehdi.nejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Hassanzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasoul-e-Akram Medical Center, Niyayesh St., Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Email
drmhxim@gmail.com
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
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 the data will become available and for how long
Since 6 months after study results are published
To whom data/document is available
All who request
Under which criteria data/document could be used
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.
From where data/document is obtainable
Sending email to the corresponding author of the published paper from the study
What processes are involved for a request to access data/document
Sending an official email to the corresponding author and receiving his approval