Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Missouri-Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01412684
First received: August 8, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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?


Condition Intervention
Tumor of Exocrine Pancreas
Procedure: Distal pancreatectomy with partial splenectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors Arising in the Body and Tail of the Pancreas

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Splenic function [ Time Frame: 30 days post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lymph node retrieval [ Time Frame: within 30 days post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Distal pancreatectomy with partial splenectomy
    Distal pancreatectomy with partial splenectomy
    Other Name: pancreatectomy
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?

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

surgical oncology clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412684

Locations
United States, Missouri
University of Missouri Not yet recruiting
Columbia, Missouri, United States, 65201
Contact: Michael Nicholl, MD    573-882-8454    nichollm@health.missouri.edu   
Principal Investigator: Michael Nicholl, MD         
Sub-Investigator: Paul Dale, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Michael Nicholl, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Michael Nicholl, MD/Assistant Professor of Clinical Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01412684     History of Changes
Other Study ID Numbers: MU1196577
Study First Received: August 8, 2011
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014