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This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreaticogastrostomy | Active Comparator | Pancreaticogastrostomy with external drain |
|
| Pancreaticojejunostomy | Active Comparator | Pancreaticojejunostomy with transanastomotic drain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticogastrostomy with external drain | Procedure | Pancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pancreatic Fistula (POPF) | Presence of Amylase > 3 times the upper limit of normal in surgical drains at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management | 30 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| POPF severity | POPF grade B and grade C rates | 30 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 |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Bassi, MD | Università degli studi di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Policlinico GB Rossi | Verona | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27730401 | Background | McMillan MT, Ecker BL, Behrman SW, Callery MP, Christein JD, Drebin JA, Fraker DL, Kent TS, Lee MK, Roses RE, Sprys MH, Vollmer CM Jr. Externalized Stents for Pancreatoduodenectomy Provide Value Only in High-Risk Scenarios. J Gastrointest Surg. 2016 Dec;20(12):2052-2062. doi: 10.1007/s11605-016-3289-6. Epub 2016 Oct 11. | |
| 20622661 |
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Individual Participant Data will not be shared with other researchers
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|
| Pancreaticojejunostomy with transanastomotic drain | Procedure | Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain. |
|
| 1 year |
| Mortality | Death related to surgical morbidity | 90 days |
| Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates | 90 days |
| Delayed Gastric Emptying | As defined by ISGPS, grade A, B and C rates | 90 days |
| Biliary fistula | Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out | 90 days |
| Gastrojejunal/Duodenojejunal fistula | Fistula from gastro/duodenojejunostomy | 90 days |
| Abdominal abscess | Collection >5cm in size, containing gas bubbles, determining systemic signs of infection | 90 days |
| Acute pancreatitis | Altered serum amylase count on POD 0 or POD 1 | 1 day post index surgery |
| Wound infection | Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention | 90 days |
| Blood transfusions | Need and number of packed red blood cells transfused | 90 days |
| Myocardial infarction | Myocardial necrosis | 90 days |
| Acute Kidney Failure | Abrupt change in serum creatinine >1.5 baseline value | 90 days |
| Pulmonary Embolism | Blood clots in the pulmonary arterial system | 90 days |
| Pneumonia | Bacterial infection of the lungs | 90 days |
| Respiratory insufficiency | Need for re-intubation | 90 days |
| Urinary Tract Infection | Bacterial infection of the urinary tract | 90 days |
| Cerebrovascular accidents | Stroke, hemorrhage, brain death | 90 days |
| Reoperation | Need for new surgery due to severe morbidity | 90 days |
| Readmission | New admission within 30-days of discharge from hospital | 30 days after hospital discharge |
| Time-to-adjuvant therapy | Time form index operation to the beginning of adjuvant treatment (only for malignancy) | 1 year |
| Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88. |
| 23122535 | Background | Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2. |
| 25040921 | Background | Hallet J, Zih FS, Deobald RG, Scheer AS, Law CH, Coburn NG, Karanicolas PJ. The impact of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction on pancreatic fistula after pancreaticoduodenectomy: meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Feb;17(2):113-22. doi: 10.1111/hpb.12299. Epub 2014 Jul 7. |
| 27017162 | Background | Wang SE, Chen SC, Shyr BU, Shyr YM. Comparison of Modified Blumgart pancreaticojejunostomy and pancreaticogastrostomy after pancreaticoduodenectomy. HPB (Oxford). 2016 Mar;18(3):229-35. doi: 10.1016/j.hpb.2015.09.007. Epub 2015 Nov 17. |
| 32101272 | Derived | Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035. |
| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010193 | Pancreaticojejunostomy |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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