Clinical trial NCT04275466: Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis
Official title: A Randomized Controlled Trials on the Effect of Necrotic Cavity Lavage After Laparoscope-assisted Debridement for Patients With Infected Pancreatic Necrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis,Acute Necrotizing
Pancreas Necrosis
Keywords: acute pancreatitis
infected pancreatic necrosis
laparoscope-assisted debridement
necrotic cavity lavage
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The infected pancreatic necrosis (IPN) should be treated by debridement and drainage. In recent years, the results of clinical research show that minimally invasive debridement such as video-assisted (laparoscope, nephroscope, endoscopy, etc.) and total laparoscopic debridement can significantly improve the prognosis of IPN patients. After a long period of clinical practice, laparoscope-assisted debridement was selected as the main surgical method in our center. In many large-scale clinical studies, patients after surgery underwent necrotic cavity lavage (such as small omental sac lavage, retroperitoneal space lavage, peripancreatic lavage, etc.), but its necessity and clinical significance were not clearly stated in the guidelines. At present, the clinical research mainly focuses on the improvement of minimally invasive debridement, and less on the necessity of lavage. In the past, necrotic cavity lavage was performed in IPN patients, but long-term clinical observation showed that lavage may lead to spread of infection and increase the incidence of lower extremity venous thrombosis which is not accorded with ERAS(Enhanced Recovery After Surgery). Therefore, since 2012, our center has stopped necrotic cavity lavage for IPN patients after debridement. We retrospectively analyzed the therapeutic effect from February 2014 to August 2017 and found that even without necrotic cavity lavage, better therapeutic effect could be achieved. Meanwhile it can simplify the operation process and avoid infection spread. This treatment method provides a new idea. However, it is a retrospective study not a randomized controlled trials(RCT) which is low effectiveness of proof. Therefore, we design this RCT to verify the necessity of necrotic cavity lavage after laparoscope-assisted debridement for patients with infected pancreatic necrosis.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of IPN
2. onset time of \>4 weeks
3. performance of LAD for IPN
4. provision of written informed consent

Exclusion Criteria:

1. the highest temperature in 24 hours of ≥38.5ºC
2. new organ failure occurring within 24 hours after the operation
3. digestive tract fistula, biliary tract or digestive tract obstruction, or bleeding occurring within 24 hours after the operation
4. abdominal pressure of ≥10 mmHg within 24 hours after the operation
5. traumatic pancreatitis or a pancreatic fistula-related infection after the pancreatic operation

Primary outcomes:
measure: sum rate of mortality and major complications
timeFrame: 1 year
Secondary outcomes:
measure: physiological parameter
timeFrame: through study completion, an average of 2 months
measure: physiological parameter
timeFrame: through study completion, an average of 2 months
measure: assay index
timeFrame: through study completion, an average of 2 months
measure: assay index
timeFrame: through study completion, an average of 2 months
measure: assay index
timeFrame: through study completion, an average of 2 months
measure: assay index
timeFrame: through study completion, an average of 2 months
measure: incidence of peritonitis and lower extremity deep vein thrombosis
timeFrame: through study completion, an average of 2 months
measure: Acute Physiology and Chronic Health Evaluation (range:0-71)
timeFrame: through study completion, an average of 2 months
measure: Total stay in hospital
timeFrame: through study completion, an average of 2 months
measure: Length of stay in Intensive Care Unit
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Fei Li, MD
role: PRINCIPAL_INVESTIGATOR
References: