Closure of the pancreatic duct after distal pancreatectomy

Appropriate closure of the pancreatic remnant after distal pancreatectomy is
still debated. A variety of procedures have been recommended to reduce the
frequency of pancreatic fistula. Resections of the pancreas reaching the left
side of the superior mesenteric vein are defined as distal pancreatectomy. They
are performed less often than resections of the pancreatic head (20 to 30% of
all pancreatic resections owing to a lower incidence of pancreatic disease and
later appearance of clinical symptoms in this part of the organ. However,
continuously improving imaging and diagnostic techniques have resulted in an
increase in the frequency of the procedure. Most resections are performed
electively (84 per cent) for the following indications: chronic pancreatitis
(24 per cent), other benign diseases (22 per cent), malignant diseases (18 per
cent), neuroendocrine tumours (14 per cent) and cysts of the pancreas (6 per
cent). The remaining 16 per cent are emergencies after abdominal trauma.In
recent years the mortality rate after pancreatic resection has decreased
considerably to between 0 and 6 per cent in high-volume centres, but morbidity
remains high, ranging from 10 to 47 per cent Pancreatic fistula and leakage are
the most common and clinically relevant complications, and they are thought to
depend on surgical technique and skill. Because fistula is associated with
local and general complications (pancreatic fluid collection, formation of
intra-abdominal abscesses, wound infection, delayed gastric emptying,
respiratory complications, sepsis), it has important implications for the
patient, the surgeon and the healthcare system. In general, it prolongs
hospital stay for specialized treatment, including re-operation and drainage.
The appropriate technique for closure of the pancreatic remnant is still
debated. There is no evidence whether stapled or hand sewn closure should be
preferred. Since stapled closure is not recommended for the triangular
pancreas, the thick pancreas ( > 1.5 cm), the firm or non-compressible pancreas
and in case of a resection plane to the right of the gastroduodenal artery, in
this study we will use a standardized hand sewn closure.
Topical hemostatic agents applied to the resection surface of the remnant liver
after partial liver resection have shown to be effective in preventing
postoperative bleeding. The group of van Gulik showed that application of
topical hemostatic agents, such as fibrinogen/thrombincoated collagen patch
(TachoSil®, Nycomed, UK Ltd.) has a biliostatic effect, which can be considered
an additional benefit of the use of these devices. The adhesive strength of
TachoSil on the resection surface, however, was superior to other agents.
Results of retrospective studies on recostruction techniques after
pancreatico-duodenectomy suggest that outcome with regard to pancreatic fistula
can be improved using TachoSil®.

The proposed study is a multicentre randomised controlled trial investigating
the effect of Tachosil sealing of the pancreatic remnant after distal
pancreatoduodenectomy on the development of pancreatic fistula.
Patients will be randomised to either Tachosil sealing of the pancreatic
remnant after standardized hand sewn closure or conventional closure alone.
Primary endpoint will be the development of pancreatic fistula.
Secondary endpoints will be overall mortality and morbidity and a cost
effectiveness analysis.

Prospective randomized controlled multi-centre trial with blinding for
treatment allocation of patients and medical personnel except for the surgeon.
Patients will be evaluated according to the inclusion criteria at the
outpatient clinic of participating centres. If eligible, informed consent is
obtained. Inclusion will start after approval of Medical Research Ethical
Committee

Conventional closure of the pancreatic remnant
After complete mobilisation of the pancreatic body or tail (up to the region of
the superior mesenteric vein, or at least 2-3 cm central of the planned
resection margin), the resection is performed with a surgical scalpel or
diathermia. After haemostasis the pancreatic duct is closed separately using
PDS 4x0 or 5x0. The pancreatic remnant is closed using continuous mattress
sutures with PDS 3x0 or 4x0.

Closure of the pancreatic remnant by Tachosil seal
In the Tachosil arm, pancreatic resection and transsection of the pancreatic
body will be executed with a surgical scalpel. The main pancreatic duct is
identified and closed using single stitches of 4-0 or 5-0 PDS. The parenchyma
is then closed with single stitches 3x0 or 4x0 PDS. The suture line is
reinforced by placement of a fibrin/ thrombin-coated collagen patch (TachoSil)
onto the transsected end .All participating centre receive a DVD where this
procedure is demonstrated

n.a.