Pancreaticoduodenectomy Clinical Trial
Official title:
Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?
Pancreatic resection is the only potentially curative modality of treatment for pancreatic
neoplasm. The mortality associated with this procedure decreased rapidly in the past
decades. However, the morbidity associated with pancreatic resection remains high. The main
reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is
regarded as the most ominous complication following pancreatic resection. Its reported
incidence varies in the surgical literature from 10% to >30%.
Recently published studies showed that the placement of intraoperative drains, manipulation
with the drains, timing of removal of the drain, and especially the type of drain, have
significant effect on the postoperative complications, and especially POPF.
Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two
most commonly used systems are closed suction drainage and closed gravity drainage. Open
systems have been abandoned in most centers as they are obsolete.
Our hypothesis is that the closed suction drain will have better results as it is more
effective than the gravity drainage. However, some surgeons claim that the suction system
can actively suck the pancreatic juice through the anastomosis or suture and thus promote
the development of POPF.
The aim of this study is to compare closed suction drains and closed gravity drains after
pancreatic resection in a randomized controlled study.
The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point
is the postoperative morbidity.
Pancreatic resection is the only potentially curative modality of treatment for pancreatic
neoplasm. The mortality associated with this procedure decreased rapidly in the past
decades. However, the morbidity associated with pancreatic resection remains high. The main
reason for postoperative morbidity is postoperative pancreatic fistula, which is regarded as
the most ominous complication following pancreatic resection. Its reported incidence varies
in the surgical literature from 10% to >30%.
Recently published studies showed that the placement of intraoperative drains, manipulation
with the drains, timing of removal of the drain, and especially the type of drain, have
significant effect on the postoperative complications, and especially POPF.
Even though several trials showed that the routine use of intraoperatively placed drains in
elective pancreatectomy does not reduce postoperative morbidity, most of the high-volume
pancreatic surgery centers still place the drains routinely. The theoretical advantage of
drainage is to identify an early bile or pancreatic leak, or postoperative hemorrhage; and
therefore allow for early treatment of the complication; or in some cases, the drain would
control the leak without necessity of reintervention.
Two large studies compared early versus late removal of the intraoperatively placed drains.
The first published by Kawai et al. was a cohort study, including 104 patients. The second
one published by Bassi et al. was prospective randomized trial including 114 patients. Both
studies clearly showed that the group of patients with early drain removal has superior
results, lower rate of POPF and lower morbidity.
Controversy exists regarding the type of intraoperatively placed drain. The surgeons in the
USA usually use the closed suction drainage system. On the other hand, European and Asian
surgeons usually prefer open Penrose system, closed gravity drainage, or a combination of
both. The closed suction drainage system uses slight under pressure to drain the fluid from
the abdominal cavity. It is more effective than other systems, and thus advantageous.
However, some surgeons claim that the suction system can actively suck the pancreatic juice
through the anastomosis or suture and thus promote the development of POPF.
Only one study published by Schmidt et al. compared closed suction drainage system with
gravity drainage. However, this study collected results over a very long period, and the
comparison of the drains was not primary end-point of the study. Randomized controlled
trials comparing various drains were published in cardiac surgery.
The situation in pancreatic surgery is specific. The pancreatic anastomosis or suture line
is not water-tight in large proportion of cases. It is due to the character of pancreatic
parenchyma. Especially in soft pancreas, the stitches can cut through and cause leak of the
suture line or anastomosis. Therefore, pancreatic leak is not rare after pancreatic
resections. Most of the POPF are grade A according to the ISGPF classification; with no
clinical consequences. The aim of the postoperative management should prevent the POPF
become clinically more severe (grade B and C). And the manipulation with the drains, and
especially the type of drain, seem to play a major role.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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