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

NCT02573389 | Suspended Phase 3 DMC

• 2 other identifiers: KPSC IRB 10705KPSC IRB10705
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreatitis

Keywords

pancreatic fistula, pancreatectomy, endoscopic stenting, pancreatic stenting, distal pancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Device: Boston Scientific or Cook pancreatic duct stents

Interventions

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.

Prospective "stented"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age 18 years of age and older
• Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas.

You may not qualify if:

• Pediatric patients younger than age 18
• Pregnant patients
• Patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).

Sponsors & Collaborators

• Kaiser Permanente: lead

Related Publications (5)

• 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.

  PMID: 23043660 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.

  PMID: 25392839 BACKGROUND

• 3. American Society for Gastrointestinal Endoscopy (ASGE) Technology Assessment Committee. Status evaluation reports: Pancreatic and biliary stents. Gastrointest Endosc. 2013;77(3):319-327.

  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.

  PMID: 24019766 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.

  PMID: 20598301 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Louis A DiFronzo, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: December 4, 2015
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-07