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

July 31, 2018 updated by: Kaiser Permanente

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Retrospective and prospective "non-stented"
Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017.
Experimental: Prospective "stented"
Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative pancreatic fistula
Time Frame: 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.
At 6 months when enrollment begins

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pre-operative: Pancreatitis from pancreatic duct stent
Time Frame: 1 - 2 weeks prior to distal pancreatectomy
1 - 2 weeks prior to distal pancreatectomy
Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality
Time Frame: 3 days post surgery
3 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louis A DiFronzo, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPSC IRB 10705
  • KPSC IRB10705 (Other Identifier: Kaiser Permanente Southern California IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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