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


N/A
18 Years
80 Years
Not Enrolling
Both
Tumor of Exocrine Pancreas

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Trial Information

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


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?


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Splenic function

Outcome Time Frame:

30 days post-operatively

Safety Issue:

No

Principal Investigator

Michael Nicholl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Missouri-Columbia

Authority:

United States: Institutional Review Board

Study ID:

MU1196577

NCT ID:

NCT01412684

Start Date:

September 2011

Completion Date:

September 2012

Related Keywords:

  • Tumor of Exocrine Pancreas
  • Pancreatic Neoplasms

Name

Location

University of Missouri Columbia, Missouri  65212