Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis

Not Applicable

• Conditions: Pancreatitis,Acute Necrotizing; Pancreas Necrosis
• Interventions: Procedure: necrotic cavity lavage

• Registration Number: NCT04275466
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-19
• Study Start: 2020-06-12
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18
• Primary Completion: 2021-06-12
• Study Completion: 2021-10-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
necrotic cavity lavage	necrotic cavity lavage	This arm was performed necrotic cavity lavage after debridement

Primary Outcome Measures

Name	Time	Method
sum rate of mortality and major complications	1 year	number of deaths and major complications (new organ failure or intraperitoneal hemorrhage/gastrointestinal fistula requiring surgical treatment)/total enrollment

Secondary Outcome Measures

Name	Time	Method
physiological parameter	through study completion, an average of 2 months	abdominal pressure in mmHg
Acute Physiology and Chronic Health Evaluation (range:0-71)	through study completion, an average of 2 months	The score shows the severity of the patients and higher scores mean a worse outcome
assay index	through study completion, an average of 2 months	interleukin-6 in pg/ml
incidence of peritonitis and lower extremity deep vein thrombosis	through study completion, an average of 2 months	postoperative complication
Total stay in hospital	through study completion, an average of 2 months	The time for the patient staying in hospital measured in days
Length of stay in Intensive Care Unit	through study completion, an average of 2 months	The time for the patient staying in Intensive Care Unit measured in days

Trial Locations

Locations (1)

Xuanwu hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China