Pancreatic Fistula Clinical Trial
— PREPOfficial title:
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
Verified date | September 2019 |
Source | Azienda Ospedaliera Universitaria Integrata Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 10, 2019 |
Est. primary completion date | June 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant). - Patients able to give their informed consent Exclusion criteria - Informed consent withdrawal - Impossibility to undergo surgery for any reason - Use of glues or biological matrices to protect the anastomosis - Fistula Risk Score < 7 - Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed) - Wrong randomization |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Policlinico GB Rossi | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2016 Oct 11. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | POPF severity | POPF grade B and grade C rates | 30 days post-operative | |
Secondary | 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 | |
Secondary | Mortality | Death related to surgical morbidity | 90 days | |
Secondary | Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates | 90 days | |
Secondary | Delayed Gastric Emptying | As defined by ISGPS, grade A, B and C rates | 90 days | |
Secondary | Biliary fistula | Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out | 90 days | |
Secondary | Gastrojejunal/Duodenojejunal fistula | Fistula from gastro/duodenojejunostomy | 90 days | |
Secondary | Abdominal abscess | Collection >5cm in size, containing gas bubbles, determining systemic signs of infection | 90 days | |
Secondary | Acute pancreatitis | Altered serum amylase count on POD 0 or POD 1 | 1 day post index surgery | |
Secondary | Wound infection | Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention | 90 days | |
Secondary | Blood transfusions | Need and number of packed red blood cells transfused | 90 days | |
Secondary | Myocardial infarction | Myocardial necrosis | 90 days | |
Secondary | Acute Kidney Failure | Abrupt change in serum creatinine >1.5 baseline value | 90 days | |
Secondary | Pulmonary Embolism | Blood clots in the pulmonary arterial system | 90 days | |
Secondary | Pneumonia | Bacterial infection of the lungs | 90 days | |
Secondary | Respiratory insufficiency | Need for re-intubation | 90 days | |
Secondary | Urinary Tract Infection | Bacterial infection of the urinary tract | 90 days | |
Secondary | Cerebrovascular accidents | Stroke, hemorrhage, brain death | 90 days | |
Secondary | Reoperation | Need for new surgery due to severe morbidity | 90 days | |
Secondary | Readmission | New admission within 30-days of discharge from hospital | 30 days after hospital discharge | |
Secondary | Time-to-adjuvant therapy | Time form index operation to the beginning of adjuvant treatment (only for malignancy) | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01696903 -
Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT01301222 -
Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
|
Phase 4 | |
Recruiting |
NCT05155878 -
Prognostic Factors in Periampullary Tumors and Cysts
|
||
Terminated |
NCT03757455 -
ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy
|
N/A | |
Recruiting |
NCT05212350 -
Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS
|
N/A | |
Completed |
NCT04609137 -
Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)
|
N/A | |
Recruiting |
NCT04798560 -
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
|
||
Completed |
NCT03627559 -
Early Detection of Anastomotic Leakage by Microdialysis Catheters
|
||
Completed |
NCT01550406 -
Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy
|
Phase 4 | |
Recruiting |
NCT04783831 -
Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
|
||
Not yet recruiting |
NCT05387538 -
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
|
N/A | |
Active, not recruiting |
NCT02775227 -
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
|
Phase 4 | |
Completed |
NCT02790333 -
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula
|
N/A | |
Not yet recruiting |
NCT05657366 -
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
|
N/A | |
Completed |
NCT03419676 -
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
|
Phase 3 | |
Recruiting |
NCT05297136 -
Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy
|
N/A | |
Completed |
NCT00931554 -
Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
|
N/A | |
Completed |
NCT00679952 -
Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
|
Phase 3 | |
Recruiting |
NCT04380506 -
Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management
|
N/A | |
Recruiting |
NCT06283160 -
Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy
|