Pancreatic Duct Stenting to Prevent Postoperative Pancreatic Fistula (POPF) After Distal Pancreatectomy

Pancreatitis Clinical Trial

Official title:

A Pilot Study on the Effect of Transampullary Pancreatic Duct Stenting on Postoperative Pancreatic Fistula Rate After Distal Pancreatectomy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02573389
• Other study ID #: KPSC IRB 10705
• Secondary ID: KPSC IRB10705
• Status: Suspended
• Phase: Phase 3
• Start date: December 4, 2015
• Est. completion date: January 2020

Study information

• Verified date: July 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients age 18 years of age and older

2. Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas.

Exclusion Criteria:

1. Pediatric patients younger than age 18

2. Pregnant patients

3. Patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatitis

Intervention

Device:
• Boston Scientific or Cook pancreatic duct stents
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

References & Publications (5)

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. Review. Erratum in: Gastrointest Endosc. 2013 Jul;78(1):193-5. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Effect size is smaller than needed to reach statistical difference even if number of enrollment is completed in one year.; Adverse events occurring from the pancreatic duct stenting itself, which include pseudocyst, delaying surgery, pancreatitis requiring prolonged hospital admission, or death.; There is statistical significant difference between control and intervention groups.	At 6 months when enrollment begins
Secondary	Pre-operative: Pancreatitis from pancreatic duct stent		1 - 2 weeks prior to distal pancreatectomy
Secondary	Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality		3 days post surgery