Prospectively Randomized Trial Using Perioperative Low-dose Octreotide to Prevent
Organ-related and General Complications after Pancreatic Surgery and
Pancreatico-jejunostomy
Uwe J. Hesse, M.D., Ph.D.,
1
* Christophe DeDecker, M.D.,
1
Philippe Houtmeyers, M.D.,
1
Pieter Demetter, M.D.,
Ph.D.,
1
Wim Ceelen, M.D.,
1
Piet Pattyn, M.D., Ph.D.,
1
Roberto Troisi, M.D., Ph.D.,
1
Bernard deHemptinne, M.D.
1
1
Department of Surgery, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium
2
Department of Pathology, Ghent University Hospital, De Printelaan 185, 9000, Ghent, Belgium
Published Online: September 8, 2005
Abstract. The aim of the present study was to evaluate the influence of
low-dose perioperative octreotide on the prevention of complications
(pancreatic fistula and general complications) in patients undergoing
pancreatic surgery followed by pancreaticojejunostomy. A total of 105
patients were randomized to receive either octreotide 0.1 mg subcutane-
ously 3 times/day for a total of 7 days or no octreotide. The primary
endpoints were the occurence of a pancreatic fistula and or general
complications, including extended length of hospital stay. There were 25
surgical draining procedures performed and 80 duodenopancreatecto-
mies with or without preservation of the pylorus. In all, 25 (23.8%) of the
patients were treated for chronic pancreatitis, 8 (7.6%) for benign tu-
moral disease, and 72 (68.6%) for carcinoma. All patients underwent
pancreaticojejunostomy.
A group of 55 patients received octreotide, and 50 others did not.
The incidence of fistula formation in the octreotide group was
9.1% (n = 5) and that in the control group was 8% (n = 4), for a
total incidence of 8.5%. The difference between the two groups
was not statistically significant. There was one death in the
octreotide group and none in the control group, for an overall
mortality of 0.9%. The morbidity, except fistulae, was 10.9% in the
octreotide group and 12% in the control group. The length of
hospital stay was 23.1 – 15.1 days in the group receiving octreo-
tide and 20.4 – 8.1 days in the control group (p = 0.808). Strat-
ifying the data for duodenopancreatectomy and for draining
procedures, there was no difference between the groups. In pa-
tients undergoing pancreatic surgery and pancreaticojejunostomy,
the perioperative use of 3 · 0.1 mg octreotide for 7 days does not
reduce general complications or fistula formation.
In recent years there has been steady improvement in results of
pancreatic surgery, marked particularly by decreases in mortality
and morbidity [1–6]. Advanced surgical techniques and a better
understanding of pancreatic pathophysiology have led to im-
proved patient selection and perioperative medical management
of these patients [5–7]. However, there is ongoing disagreement in
the literature on the perioperative use of somatostatin or octre-
otide [8–12] in the prevention of postoperative pancreatic com-
plications recently summarized in a meta-analysis by Scha¨fer et al.
[13] and in a systemic review by Li-Ling and Irving [14]. In par-
ticular, the decreasing effect of prophylactic treatment when
overall fistula formation is under 10% in specialized units seems
to be important when costs are considered in the disease man-
agement of these patients.
The aim of this trial was to assess the effect of perioperative
octreotide given at the time of operation in a dose of 3 · 0.1 mg sc
for 7 days on the development of pancreatic fistula formation and
general surgical complications in patients undergoing pancreatic
surgery followed by pancreaticojejunostomy.
Materials and Methods
The study was designed as a single-center open-label prospec-
tively randomized trial. All patients aged 16 to 86 years subjected
to pancreatic surgery and subsequent pancreaticojejunostomy
were included in the study. on a consecutive basis without
exception. Not included were patients undergoing pancreatic
resections without pancreaticojejunostomy or with pancreaticog-
astrostomy.
Randomization was performed according to a computer-gen-
erated random list. As regards the pathology, patients with car-
cinoma, benign tumors, and sequelae of chronic pancreatitis were
eligible for the study.
Informed written consent was obtained from each patient, and
the study protocol was approved by the local ethical committee.
Surgical Technique
The operation was performed by three senior staff surgeons
according to standarized surgical techniques. For the intestinal
*Present address: Klinikum Stuttgart–Krankenhaus Bad Cannstatt
Priessnitzweg 24, D-70374 Stuttgart.
Correspondence to: Uwe J. Hesse, M.D., Ph.D., e-mail: uwe.uhesse@
kbc-intern.de
World J. Surg. 29, 1325–1328 (2005)
DOI: 10.1007/s00268-005-7546-1