Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors

August 4, 2016 updated by: University of Missouri-Columbia

Pilot Study of Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors Arising in the Body and Tail of the Pancreas

Most resectable tumors arising in the body or tail of the pancreas are malignancies or premalignancies which are surgically treated with distal pancreatectomy in combination with splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is necessary to complete an oncologically sound operation. Two techniques for spleen preserving distal pancreatectomy have been described, but only a small number of lesions are amenable to spleen preserving pancreas surgery because these operation compromise oncologic principles. Removal of a normal spleen usually does not cause immediate consequences but can make patients vulnerable to life threatening infections. Asplenic patients must be vigilant for these infections and antibiotic prophylaxis is recommended anytime a fever occurs. Splenectomy results in measurable changes in the cellular components of the blood. If thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet treatment.

Some childhood hematologic disorders such as hereditary spherocytosis are successfully treated with partial splenectomy. The post-surgical remnant spleen has been shown to be viable and functional. Both hematologic and immunologic function of the spleen seems to be preserved in most patients. Partial splenectomy has also been successful ly employed to treat benign and malignant lesions of the spleen. Unfortunately these indications for surgery are rare and so the experience with partial splenectomy is small.

To date, distal pancreatectomy with partial splenectomy has not been described in the medical literature. The investigators have devised a surgical procedure combining distal pancreatectomy with partial splenectomy, in principal allowing preservation of splenic function without compromise of oncologic principles. This procedure is possible now because of new technology which allows for near bloodless transection of solid organs. These instruments are routinely used in liver, kidney and pancreas surgery. There are scattered reports of successful use of these instruments in splenic transection, but there is no large experience to date.

The study intends to answer the question, is the proposed procedure, distal pancreatectomy and partial splenectomy, a viable alternative to the current standard of care, distal pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of pancreas lesions arising in the body or tail of the pancreas?

Study Overview

Status

Status

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

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

Resectable tumors arising in the body or tail of the pancreas are malignancies or premalignancies which are surgically treated with distal pancreatectomy in combination with splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is necessary to complete an oncologically sound operation. Two techniques for spleen preserving distal pancreatectomy have been described, but only a small number of lesions are amenable to spleen preserving pancreas surgery because these operation compromise oncologic principles. Removal of a normal spleen usually does not cause immediate consequences but can make patients vulnerable to life threatening infections. Asplenic patients must be vigilant for these infections and antibiotic prophylaxis is recommended anytime a fever occurs. Splenectomy results in measurable changes in the cellular components of the blood. If thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet treatment.

Some childhood hematologic disorders such as hereditary spherocytosis are successfully treated with partial splenectomy. The post-surgical remnant spleen has been shown to be viable and functional. Both hematologic and immunologic function of the spleen seems to be preserved in most patients. Partial splenectomy has also been successful ly employed to treat benign and malignant lesions of the spleen. Unfortunately these indications for surgery are rare and so the experience with partial splenectomy is small.

To date, distal pancreatectomy with partial splenectomy has not been described in the medical literature. We have devised a surgical procedure combining distal pancreatectomy with partial splenectomy, in principal allowing preservation of splenic function without compromise of oncologic principles. This procedure is possible now because of new technology which allows for near bloodless transection of solid organs. These instruments are routinely used in liver, kidney and pancreas surgery. There are scattered reports of successful use of these instruments in splenic transection, but there is no large experience to date.

The study intends to answer the question, is the proposed procedure, distal pancreatectomy and partial splenectomy, a viable alternative to the current standard of care, distal pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of pancreas lesions arising in the body or tail of the pancreas?

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.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

surgical oncology clinic

Description

Inclusion Criteria:

  • Patients with solid or cystic neoplasms of the pancreas who are being considered for distal pancreatectomy/splenectomy to be performed in either an open, laparoscopic, of da Vinci assisted fashion.
  • No evidence of metastatic disease
  • No evidence of local invasion into surrounding organs
  • ECOG performance status <3
  • Age 18 years or greater
  • Participants will provide written informed consent to be part of the study

Exclusion Criteria:

  • Age less than 18 years old
  • Women who are pregnant
  • Known hereditary bleeding disorder with history of post-operative hemorrhage
  • Patients maintained on chronic anticoagulation (eg Coumadin therapy)
  • Known hematogenous disorder
  • Previous gastric fundoplication procedure or any procedure which interrupts the short gastric blood supply to the spleen
  • Known primary or secondary malignancy of the spleen
  • Pancreatic tumors which invade surrounding structures
  • Prisoners
  • Patients with impaired decision-making skills

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

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
Time Frame
Splenic function
Time Frame: 30 days post-operatively
30 days post-operatively

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
Lymph node retrieval
Time Frame: within 30 days post-operatively
within 30 days post-operatively

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.
University of Missouri-Columbia

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: Michael Nicholl, MD, University of Missouri-Columbia

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

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.
September 1, 2011

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.
September 1, 2011

Study Completion (Actual)

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.
September 1, 2011

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).
August 8, 2011

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.
August 8, 2011

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.
August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

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 8, 2016

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.
August 4, 2016

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.
May 1, 2016

More Information

Terms related to this study

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.
  • MU1196577

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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