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NCT04275466: NCLAD
Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis
NA trial testing necrotic cavity lavage in Pancreatitis,Acute Necrotizing in 112 participants. Status unknown.
12 June 2021
Quick facts
| Lead sponsor | Xuanwu Hospital, Beijing |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 12 June 2020 |
| Primary completion | 12 June 2021 |
| Estimated completion | 12 October 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- necrotic cavity lavage
Conditions studied
- Pancreatitis,Acute Necrotizing — all drugs for Pancreatitis,Acute Necrotizing →
- Pancreas Necrosis — all drugs for Pancreas Necrosis →
Sponsor
Xuanwu Hospital, Beijing
Who can join
Adults 18 to 80, any sex, with Pancreatitis,Acute Necrotizing or Pancreas Necrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04275466 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xuanwu Hospital, Beijing
- Last refreshed: 18 June 2020
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