Endoscopic necrosectomy for treatment of infected walled-off pancreatic necrosis

Not Applicable

Recruiting

• Conditions: Acute pancreatitis; Infected walled off necrosis.; Acute pancreatitis, unspecified; K85.9

• Registration Number: IRCT20220718055486N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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, ...)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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).;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.