Laparoscopic Versus Open Pancreatectomy

Open distal pancreatectomy with or without splenectomy has been commonly employed for the
treatment of a variety of pancreatic diseases. Although many general surgical procedures
have been increasingly performed laparoscopically or with laparoscopic assistance, until the
current decade, laparoscopic pancreatic surgery had not been performed. Surgeons at Indiana
University Hospital have safely applied laparoscopic surgery to very select patients with
pancreatic disease since 2003. Recently, the outcomes of laparoscopic distal pancreatectomy
at Indiana University in combination with multiple other institutions were reviewed and
presented at the American Surgical Association Meeting 2008. These data suggest that
laparoscopic when compared with open distal pancreatectomy may be associated with lower
blood loss (357 vs. 588 cc, p<0.01), fewer complications (40 vs. 57%, p<0.01), and shorter
hospital stays (5.9 vs. 9.0 days, p<0.01). Furthermore, the laparoscopic approach was an
independent predictor of shorter hospital stays. The main criticism of this retrospective
study and similarly designed studies is that there is likely to be a selection bias in
patients who undergo laparoscopic distal pancreatectomy which may account for the apparent
positive results in favor of laparoscopic distal pancreatectomy. In other words, patient
factors, not the operative approach may be more predictive of the outcome.

Based on these data, however, laparoscopic distal pancreatectomy appears to be at least as
safe as open distal pancreatectomy. Currently, either technique is considered the "standard
of care" at Indiana University Hospital as well as several other institutions in the US with
expertise in laparoscopic pancreas surgery. To determine whether laparoscopic distal
pancreatectomy is truly superior to open distal pancreatectomy in terms of outcomes, we have
proposed to randomize patients to laparoscopic vs open distal pancreatectomy. In addition
to the randomization, patients will be preoperatively stratified according to whether there
is a diagnosis of pancreatic adenocarcinoma, so outcomes in this specific group of patients
may be examined. Patients with adenocarcinoma will be randomized separately to insure equal
groups in laparoscopic and open distal pancreatectomy groups for this specific diagnosis.
Patients with neuroendocrine/islet cell tumors will also be randomized separately to insure
equal groups in laparoscopic and open distal pancreatectomy groups for this specific
diagnosis. Laparoscopic distal pancreatectomy for adenocarcinoma and neuroendocrine/islet
cell tumors is uncommon (e.g., only 9 adenocarcinomas in last 5 years were performed
laparoscopically at IU), thus it is clear from the outset that conclusions will be limited
about patients with these diagnoses. Although this is being submitted as a single
institution study, it will be strongly considered for multi-institutional study design in
the near future. Patients will be enrolled on an intention-to-treat manner. Thus, patients
who are randomized to laparoscopic distal pancreatectomy who require conversion to open
pancreatectomy will still be included in the laparoscopic group in the overall comparative
analyses. Subgroup analyses, however, will also be performed excluding this cross-over
group.

Objectives:

Primary: The primary objective is to determine whether laparoscopic distal pancreatectomy
is associated with improved outcomes compared to open distal pancreatectomy. Retrospective
data suggests that blood loss, overall complication rate and hospital length of stay are
positively influenced by the laparoscopic approach. Thus, these specific outcomes will be
examined:

1. estimated blood loss

2. overall complication rate

3. hospital length of stay

Secondary:

1. to determine whether laparoscopic distal pancreatectomy is safe in patients with
pancreatic adenocarcinoma

2. to establish a distal pancreatectomy registry