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

Capital Medical University

Status: Unknown

Conditions: Pancreatitis,Acute Necrotizing; Pancreas Necrosis

Treatments: Procedure: necrotic cavity lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT04275466

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Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

necrotic cavity lavage

Experimental group

Description:

This arm was performed necrotic cavity lavage after debridement

Treatment:

Procedure: necrotic cavity lavage

non-necrotic cavity lavage

No Intervention group

Description:

This arm was not performed necrotic cavity lavage after debridement