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As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.
In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low and medium risk(a-FRS)lavage | Experimental | alternative pancreatic fistula risk score system,a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage |
|
| low and medium risk(a-FRS) no lavage | No Intervention | alternative pancreatic fistula risk score system,a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage | |
| high risk(a-FRS)lavage | Experimental | alternative pancreatic fistula risk score system,a-FRS high risk group (>20%) lavage |
|
| high risk(a-FRS)no lavage | No Intervention | alternative pancreatic fistula risk score system,a-FRS high risk group (>20%) no lavage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritoneal lavage | Procedure | Continuous abdominal flushing with normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pancreatic Fistula (POPF) | Presence of Amylase > 3 times the upper limit of normal in surgical drains | 30 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary fistula | Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out | 90 days post-operative |
| Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huanbing Zhu, PhD | Contact | 15857174159 | juvanbn@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| 90 days post-operative |
| Mortality | Death related to surgical morbidity | 90 days post-operative |
| Delayed Gastric Emptying | As defined by ISGPS, grade A, B and C rates | 90 days post-operative |
| Abdominal abscess or infection | Collection >5cm in size, containing gas bubbles, determining systemic signs of infection | 90 days post-operative |
| Gastrojejunal/Duodenojejunal fistula | Fistula from gastro/duodenojejunostomy | 90 days post-operative |
| Wound infection | Superficial and Deep Surgical Site Incisional Infection | 90 days post-operative |
| Length of Hospital Stay | calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission | 1 year post-operative |
| Reoperation | Need for new surgery due to severe morbidity | 90 days post-operative |
| Readmission | New admission within 30-days of discharge from hospital | 30 days post-operative |
| drainage tube duration | Retention time of abdominal drainage tube | 90 days post-operative |
| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010533 | Peritoneal Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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