Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Study Overview
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Brief Summary
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The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy. A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.

Detailed Description
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Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy. A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.

Official Title
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Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Conditions
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Pancreas Cancer, Surgery-Complications, Biliary Fistula

Intervention / Treatment
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* Procedure: Preoperative biliary drainage (ERC og PTC-aided)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who had undergone pancreatoduodenectomy Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative biliary drainage<br>Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy | Procedure: Preoperative biliary drainage (ERC og PTC-aided)<br>* Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC<br>|
| No preoperative biliary drainage<br>Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complication score (Clavien-Dindo) | The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality. | During hospital admission, median time 13 days, up to 390 days. | 
| 30-day Mortality | 30-day mortality rate post-pancreatoduodenectomy | up to 30 days | 
| 90-day Mortality | 90-day mortality rate post-pancreatoduodenectomy | up to 90 days | 
| Length of Hospital Stay | Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge. | Days from admission until discharge, up to 390 days, median time 13 days | 
| 30-day Readmission | Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy. | up to 30-days from hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications following preoperative bile duct drainage | Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis | up to 7 days after bile duct drainage | 
| Time from Bile Duct Drainage to Pancreatoduodenectomy | Time from Bile Duct Decompression to pancreatoduodenectomy. | Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days | 
| Histological Specimen | Histological diagnosis of the resection specimens divided in malignant (ductal adenocarcinoma, cholangiocarcinoma, papillary carcinoma, duodenal adenocarcinoma, neuroendocrine tumor, other pancreatic carcinoma, other malignancy in the pancreas) and benign (IPMN, other benign diseases). | Obtained within 21 days after resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatoduodenectomy, complications, percutaneous transhepatic biliary drainage