Tumor of Exocrine Pancreas Clinical Trial
Official title:
Pilot Study of Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors Arising in the Body and Tail of the Pancreas
| Verified date | May 2016 |
| Source | University of Missouri-Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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?
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Missouri | Columbia | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| University of Missouri-Columbia |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Splenic function | 30 days post-operatively | No | |
| Secondary | Lymph node retrieval | within 30 days post-operatively | No |