- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275466
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Chongchong Gao, MD
- Phone Number: +86-15110182365
- Email: scientificsalon@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital Capital Medical University
-
Contact:
- Xinya Wang
- Phone Number: +86-18610240907
- Email: 346683615@qq.com
-
-
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:
- diagnosis of IPN
- onset time of >4 weeks
- performance of LAD for IPN
- provision of written informed consent
Exclusion Criteria:
- the highest temperature in 24 hours of ≥38.5ºC
- new organ failure occurring within 24 hours after the operation
- digestive tract fistula, biliary tract or digestive tract obstruction, or bleeding occurring within 24 hours after the operation
- abdominal pressure of ≥10 mmHg within 24 hours after the operation
- 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
|
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- lifei
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.
Clinical Trials on Pancreatitis,Acute Necrotizing
-
Centre Hospitalier Universitaire de NiceRecruiting
-
Tianjin Nankai HospitalCompletedAcute PancreatitisChina
-
Orlando Health, Inc.Mayo Clinic; University of Alabama at Birmingham; University of Southern California and other collaboratorsActive, not recruitingPancreatitis,Acute NecrotizingUnited States
-
University of OuluCopenhagen University Hospital, HvidovreUnknownAcute Necrotizing PancreatitisFinland
-
Sichuan Academy of Medical SciencesPeking Union Medical College HospitalCompleted
-
Northern State Medical UniversityCompleted
-
Erzhen ChenRenJi HospitalUnknownPancreatitis,Acute NecrotizingChina
-
John Gasdal KarstensenCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedAcute Pancreatitis NecrotizingIndia
-
Postgraduate Institute of Medical Education and...RecruitingAcute Necrotizing PancreatitisIndia
Clinical Trials on necrotic cavity lavage
-
US Department of Veterans AffairsCompleted
-
Kinamed IncorporatedUS Department of Veterans AffairsCompletedPostoperative Complications | Memory DisordersUnited States
-
Sheba Medical CenterRabin Medical Center; Meir Medical Center; Shaare Zedek Medical CenterRecruitingOvarian Cancer | Fallopian Tube Cancer | Ovarian Carcinoma | Serous Cystadenocarcinoma | Primary Peritoneal CarcinomaIsrael
-
Erasme University HospitalFonds National de la Recherche ScientifiqueCompleted
-
Prelife KftCompletedInfertility, Female | IVF
-
Universitätsmedizin MannheimHeidelberg UniversityTerminatedAdenocarcinoma | Stomach NeoplasmsGermany
-
Datar Cancer Genetics LimitedNational University of Singapore; Test At Home Pte. LtdNot yet recruiting
-
dina darwishCompletedPrimary Teeth | Dental Pulp RegenerationEgypt
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPancreatic Fistula | Pancreaticoduodenal; FistulaChina
-
United States Naval Medical Center, San DiegoNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsNot yet recruitingTibial Fractures | Post-traumatic; Arthrosis | Post-Traumatic Osteoarthritis of Ankle