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

Kaiser Permanente

Status and phase: Suspended; Phase 3

Conditions: Pancreatitis

Treatments: Device: Boston Scientific or Cook pancreatic duct stents

Study type: Interventional

Funder types: Other

Identifiers

NCT02573389

KPSC IRB 10705

KPSC IRB10705 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Retrospective and prospective "non-stented"

No Intervention group

Description:

Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017.

Prospective "stented"

Experimental group

Description:

Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.

Treatment:

Device: Boston Scientific or Cook pancreatic duct stents