Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| necrotic cavity lavage | Experimental | This arm was performed necrotic cavity lavage after debridement |
|
| non-necrotic cavity lavage | No Intervention | This arm was not performed necrotic cavity lavage after debridement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| necrotic cavity lavage | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| physiological parameter | body temperature in degree centigrade | through study completion, an average of 2 months |
| physiological parameter | abdominal pressure in mmHg |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chongchong Gao, MD | Contact | +86-15110182365 | scientificsalon@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Fei Li, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| through study completion, an average of 2 months |
| assay index | white blood cell in 109/L | through study completion, an average of 2 months |
| assay index | c-reactive protein in mg/L | through study completion, an average of 2 months |
| assay index | procalcitonin in ng/ml | through study completion, an average of 2 months |
| assay index | interleukin-6 in pg/ml | through study completion, an average of 2 months |
| incidence of peritonitis and lower extremity deep vein thrombosis | postoperative complication | 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 | through study completion, an average of 2 months |
| Total stay in hospital | 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 | The time for the patient staying in Intensive Care Unit measured in days | through study completion, an average of 2 months |