Pancreatitis,Acute NecrotizingNCLADNCT04275466
Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis
A study testing necrotic cavity lavage in people with Pancreatitis,Acute Necrotizing and Pancreas Necrosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis,Acute Necrotizing, Pancreas Necrosis
- What is being tested?
- necrotic cavity lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2020to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of IPN
- onset time of >4 weeks
- performance of LAD for IPN
- provision of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Xinya Wang, +86-18610240907, 346683615@qq.com
About this study
Official title: 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.
- Conditions
- Pancreatitis,Acute Necrotizing, Pancreas Necrosis
- Being tested
- necrotic cavity lavage
- Keywords
- acute pancreatitis, infected pancreatic necrosis, laparoscope-assisted debridement, necrotic cavity lavage
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
necrotic cavity lavageProcedure or surgery
- 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.
- 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.
- 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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| necrotic cavity lavage | Experimental | This arm was performed necrotic cavity lavage after debridement Receives: Procedure: necrotic cavity lavage |
| non-necrotic cavity lavage | No intervention | This arm was not performed necrotic cavity lavage after debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
sum rate of mortality and major complications
number of deaths and major complications (new organ failure or intraperitoneal hemorrhage/gastrointestinal fistula requiring surgical treatment)/total enrollment
Measured: 1 year
Secondary outcomes (10)
physiological parameter
body temperature in degree centigrade
Measured: through study completion, an average of 2 months
physiological parameter
abdominal pressure in mmHg
Measured: through study completion, an average of 2 months
assay index
white blood cell in 109/L
Measured: through study completion, an average of 2 months
assay index
c-reactive protein in mg/L
Measured: through study completion, an average of 2 months
assay index
procalcitonin in ng/ml
Measured: through study completion, an average of 2 months
assay index
interleukin-6 in pg/ml
Measured: through study completion, an average of 2 months
incidence of peritonitis and lower extremity deep vein thrombosis
postoperative complication
Measured: through study completion, an average of 2 months
Acute Physiology and Chronic Health Evaluation (range:0-71)
The score shows the severity of the patients and higher scores mean a worse outcome
Measured: through study completion, an average of 2 months
Total stay in hospital
The time for the patient staying in hospital measured in days
Measured: through study completion, an average of 2 months
Length of stay in Intensive Care Unit
The time for the patient staying in Intensive Care Unit measured in days
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start12 Jun 2020
- Primary completion12 Jun 2021 (estimated)
- Study completion12 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis,Acute NecrotizingStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Li, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275466
- Sponsor's protocol ID
- lifei
- Acronym
- NCLAD
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trials on the Effect of Necrotic Cavity Lavage After Laparoscope-assisted Debridement for Patients With Infected Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT04275466
- Acronym / sponsor ID
- NCLAD / lifei
- Conditions
- Pancreatitis,Acute Necrotizing, Pancreas Necrosis
- Keywords
- acute pancreatitis, infected pancreatic necrosis, laparoscope-assisted debridement, necrotic cavity lavage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 12 Jun 2021 (estimated)
- Study completion
- 12 Oct 2021 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| necrotic cavity lavage | Experimental | Procedure: necrotic cavity lavageThis arm was performed necrotic cavity lavage after debridement |
| non-necrotic cavity lavage | No intervention | –This arm was not performed necrotic cavity lavage after debridement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of IPN
- onset time of >4 weeks
- performance of LAD for IPN
- provision of written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| necrotic cavity lavage1. 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. | Procedure or surgery | necrotic cavity lavage |
Primary outcome
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
10 secondary outcomes
physiological parameter
Time frame: through study completion, an average of 2 months
physiological parameter
Time frame: through study completion, an average of 2 months
assay index
Time frame: through study completion, an average of 2 months
assay index
Time frame: through study completion, an average of 2 months
assay index
Time frame: through study completion, an average of 2 months
assay index
Time frame: 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
Acute Physiology and Chronic Health Evaluation (range:0-71)
Time frame: through study completion, an average of 2 months
Total stay in hospital
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Li, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing necrotic cavity lavage in people with Pancreatitis,Acute Necrotizing and Pancreas Necrosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chongchong Gao, MD (+86-15110182365, scientificsalon@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sum rate of mortality and major complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.