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

Phase 3

Suspended

• Conditions: Pancreatitis
• Interventions: Device: Boston Scientific or Cook pancreatic duct stents

• Registration Number: NCT02573389
• Lead Sponsor: Kaiser Permanente

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-09
• Study Start: 2015-12-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective "stented"	Boston Scientific or Cook pancreatic duct stents	Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.

Primary Outcome Measures

Name	Time	Method
Post-operative pancreatic fistula	At 6 months when enrollment begins	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality	3 days post surgery
Pre-operative: Pancreatitis from pancreatic duct stent	1 - 2 weeks prior to distal pancreatectomy