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

June 16, 2020 updated by: Xuanwu Hospital, Beijing

A Randomized Controlled Trials on the Effect of Necrotic Cavity Lavage After Laparoscope-assisted Debridement for Patients With Infected Pancreatic Necrosis

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: necrotic cavity lavage
This arm was performed necrotic cavity lavage after debridement
  1. At least two 30- to 36-Fr drainage tubes will be placed into each necrotic cavity. One of these drainage tubes will be used as the lavage tube; the other tube is designed for drainage.
  2. Lavage will begin on the first day after debridement, and the relevant indices will be evaluated every 7 days to decide whether to continue the lavage.
  3. 1200 mL of normal saline will be lavaged into each necrotic cavity every day at a speed of 200 mL/h for 3 hours each time and for a total of two times. The start times of lavage will be 08:00 and 20:00.
  4. The lavage and drainage volumes of the first hour and second hour of each lavage session will be calculated. The lavage of the next hour will be stopped if the lavage volume minus the drainage volume is >100 mL.
  5. Lavage will be suspended if abdominal pain and distention occur, the maximum body temperature is >38.5ºC, or the abdominal pressure is ≥15 mmHg during the lavage procedure.
NO_INTERVENTION: non-necrotic cavity lavage
This arm was not performed necrotic cavity lavage after debridement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physiological parameter
Time Frame: through study completion, an average of 2 months
body temperature in degree centigrade
through study completion, an average of 2 months
physiological parameter
Time Frame: through study completion, an average of 2 months
abdominal pressure in mmHg
through study completion, an average of 2 months
assay index
Time Frame: through study completion, an average of 2 months
white blood cell in 109/L
through study completion, an average of 2 months
assay index
Time Frame: through study completion, an average of 2 months
c-reactive protein in mg/L
through study completion, an average of 2 months
assay index
Time Frame: through study completion, an average of 2 months
procalcitonin in ng/ml
through study completion, an average of 2 months
assay index
Time Frame: through study completion, an average of 2 months
interleukin-6 in pg/ml
through study completion, an average of 2 months
incidence of peritonitis and lower extremity deep vein thrombosis
Time Frame: through study completion, an average of 2 months
postoperative complication
through study completion, an average of 2 months
Acute Physiology and Chronic Health Evaluation (range:0-71)
Time Frame: through study completion, an average of 2 months
The score shows the severity of the patients and higher scores mean a worse outcome
through study completion, an average of 2 months
Total stay in hospital
Time Frame: through study completion, an average of 2 months
The time for the patient staying in hospital measured in days
through study completion, an average of 2 months
Length of stay in Intensive Care Unit
Time Frame: through study completion, an average of 2 months
The time for the patient staying in Intensive Care Unit measured in days
through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fei Li, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2020

Primary Completion (ANTICIPATED)

June 12, 2021

Study Completion (ANTICIPATED)

October 12, 2021

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 16, 2020

First Posted (ACTUAL)

February 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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