Randomized Controlled Trial Comparing Closed-suction Drain Versus Passive Gravity Drain Following Pancreatic Resection
Condition: Pancreaticoduodenectomy; Distal Pancreatectomy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Closed gravity drain; closed suction drain
Intervention type(s): Procedure; Procedure
Intervention description(s): passive tube drains (PFM Medical, Köln, Germany); BLAKE Silicon drains (Ethicon, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment