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| ID | Type | Description | Link |
|---|---|---|---|
| KPSC IRB10705 | Other Identifier | Kaiser Permanente Southern California IRB |
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lack of accrual due to competing study
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To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact the incidence of a post-operative pancreatic fistula, as defined by postoperative. If pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly decrease the rate of development of a post-operative pancreatic fistula after distal pancreatectomy.
Prophylactic pancreatic duct stenting is to be offered to all patients deemed a candidate for a distal pancreatectomy. This is a nonrandomized cohort study with a retrospective and prospective control group (Jan 2008 - Dec 2017 or sample size obtained) and a prospective endoscopic intervention group (September 2015 - Dec 2017 or until sample size obtained). We will then compare the rate of development of a postoperative pancreatic fistula between those patients who have preoperative stenting and those who do not. POPF will be defined as the amylase level of drain contents equaling three times or more the serum amylase on postoperative day 3, as defined by the International Study Group for Pancreatic Fistula (ISGPF) or an ICD-9 diagnosis of 577.8. The patient will have a pre-operative visit for stent placement and a post-operative visit for stent removal if still in place 4-6 weeks after distal pancreatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective and prospective "non-stented" | No Intervention | Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017. | |
| Prospective "stented" | Experimental | Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific or Cook pancreatic duct stents | Device | Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pancreatic fistula | Rate of post-operative pancreatic fistula will be evaluated at 6 months when enrollment begins. Early stop is determined under either of below conditions:
| At 6 months when enrollment begins |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative: Pancreatitis from pancreatic duct stent | 1 - 2 weeks prior to distal pancreatectomy | |
| Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality | 3 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis A DiFronzo, MD | Kaiser Permanente | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23043660 | Background | Jin T, Altaf K, Xiong JJ, Huang W, Javed MA, Mai G, Liu XB, Hu WM, Xia Q. A systematic review and meta-analysis of studies comparing laparoscopic and open distal pancreatectomy. HPB (Oxford). 2012 Nov;14(11):711-24. doi: 10.1111/j.1477-2574.2012.00531.x. Epub 2012 Aug 7. | |
| 25392839 | Background | Schoellhammer HF, Fong Y, Gagandeep S. Techniques for prevention of pancreatic leak after pancreatectomy. Hepatobiliary Surg Nutr. 2014 Oct;3(5):276-87. doi: 10.3978/j.issn.2304-3881.2014.08.08. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
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| 23410693 | Background | ASGE Technology Assessment Committee; Pfau PR, Pleskow DK, Banerjee S, Barth BA, Bhat YM, Desilets DJ, Gottlieb KT, Maple JT, Siddiqui UD, Tokar JL, Wang A, Song LM, Rodriguez SA. Pancreatic and biliary stents. Gastrointest Endosc. 2013 Mar;77(3):319-27. doi: 10.1016/j.gie.2012.09.026. |
| 24019766 | Background | Reddymasu SC, Pakseresht K, Moloney B, Alsop B, Oropezia-Vail M, Olyaee M. Incidence of pancreatic fistula after distal pancreatectomy and efficacy of endoscopic therapy for its management: results from a tertiary care center. Case Rep Gastroenterol. 2013 Aug 16;7(2):332-9. doi: 10.1159/000354136. eCollection 2013. |
| 20598301 | Background | Rieder B, Krampulz D, Adolf J, Pfeiffer A. Endoscopic pancreatic sphincterotomy and stenting for preoperative prophylaxis of pancreatic fistula after distal pancreatectomy. Gastrointest Endosc. 2010 Sep;72(3):536-42. doi: 10.1016/j.gie.2010.04.011. Epub 2010 Jul 3. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |