The polyglycolic acid (PGA) felt is a felt-like absorbable suture reinforcing material. The pancreatojejunostomy aimed at reducing POPF is not established at present. We devised a new method using doubly PGA felt. This study is a multicenter, randomized phase III trial between Japan and Korea to verify the usefulness of this double coating of PGA felt.
Pancreatojejunostomy is generally a combination of suture between the pancreatic parenchyma and the seromuscular layer of the jejunum, and duct-to-mucosa suture. The clinical study about the various kinds of pancreatojejunostomy have been reported for the purpose of lowering the frequency of POPF; however, the frequency of more than grade B POPF is still around 10 to 20%. In soft pancreas cases with unexpanded pancreatic ducts, the risk is further elevated. The polyglycolic acid (PGA) felt is an absorbable suture reinforcing material. It is generally used to reinforce sutures of fragile tissues such as the lung, bronchi, liver, and gastrointestinal tract, and to reinforce a wide range of tissue defects. Regarding pancreatojejunostomy using a PGA felt, the incidence of POPF formation was decreased in some retrospective studies; on the other hand, no significant difference was found in other study. As described above, the pancreatojejunostomy aimed at reducing POPF is not established at present. We devised a new method using doubly PGA felt. This study is a multicenter, randomized phase III trial between Japan and Korea to verify the usefulness of this double coating of PGA felt.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
514
During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil®, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.
University of Toyama
Toyama, Toyama, Japan
Incidence of a clinically relevant POPF (ISGPS grade B/C)
Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF
Time frame: within 3 months after surgery
Length of drain placement
Number of days from operation date to drain removal date (the peripancreatic drain to be removed last)
Time frame: within 3 months after surgery
Length of the hospital stay
Number of days from operation date to discharge date
Time frame: within 3 months after surgery
Incidence of overall POPF (Biochemical leak, grade B, and C)
Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria
Time frame: within 3 months after surgery
Incidence of POPF by each suturing method to approximate the pancreas and the jejunum
Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria by each suturing method to approximate the pancreas and the jejunum (Kakita, two-layer, or Blumgart)
Time frame: within 3 months after surgery
Incidence of delayed gastric emptying (DGE)
Incidence of overall DGE, according to the ISGPS criteria
Time frame: within 3 months after surgery
Incidence of intraabdominal abscess
Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification
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Time frame: within 3 months after surgery
Incidence of postpancreatectomy hemorrhage (PPH)
Incidence of overall PPH, according to the ISGPS criteria
Time frame: within 3 months after surgery
Incidence of interventional drainage
Incidence of additional drainage percutaneously or endoscopically
Time frame: within 3 months after surgery
Incidence of overall postoperative complications
Incidence of overall postoperative complications, according to Clavien-Dindo classification
Time frame: within 3 months after surgery
Incidence of POPF-related complications (POPF+DGE+abscess+PPH)
Incidence of cases in whom one of 3), 5), 6) or 7) occurred
Time frame: within 3 months after surgery
Incidence of 3-month mortality
Incidence of surgery-related deaths from operation date to postoperative 3 months
Time frame: within 3 months after surgery
Incidence of reoperation
Incidence of reoperation from operation date to postoperative 3 months
Time frame: within 3 months after surgery
Incidence of readmission
Incidence of readmission from operation date to postoperative 3 months
Time frame: within 3 months after surgery