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Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01412684
Recruitment Status : Withdrawn (Never activated)
First Posted : August 9, 2011
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Tracking Information
First Submitted Date August 8, 2011
First Posted Date August 9, 2011
Last Update Posted Date August 8, 2016
Study Start Date September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2011)
Splenic function [ Time Frame: 30 days post-operatively ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 8, 2011)
Lymph node retrieval [ Time Frame: within 30 days post-operatively ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors
Official Title Pilot Study of Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors Arising in the Body and Tail of the Pancreas
Brief Summary

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?

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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population surgical oncology clinic
Condition Tumor of Exocrine Pancreas
Intervention Procedure: Distal pancreatectomy with partial splenectomy
Distal pancreatectomy with partial splenectomy
Other Name: pancreatectomy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 12, 2016)
0
Original Estimated Enrollment
 (submitted: August 8, 2011)
10
Actual Study Completion Date September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01412684
Other Study ID Numbers MU1196577
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Missouri-Columbia
Study Sponsor University of Missouri-Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Michael Nicholl, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date May 2016