PLANET-PJ trial

JRCT ID: jRCTs042180090

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: A case diagnosed as disease of pancreatic or periampullary lesions
• Date of first enrollment: 13/03/2019
• Target sample size: 514
• Countries of recruitment: Republic of Korea,Japan
• Study type: Interventional
• Intervention(s): using doubly polyglycolic acid felt during pancreaticojejunostomy

Outcome(s)

• Primary Outcome: Incidence of a clinically relevant POPF (ISGPS grade B/C)
• Secondary Outcome: Length of the drain placement, Length of the hospital stay, Incidence of overall POPF (Biochemical leak, grade B, and C), Incidence of POPF by each suturing method to approximate the pancreas and the jejunum, Incidence of delayed gastric emptying (DGE), Incidence of intraabdominal abscess, Incidence of postpancreatectomy hemorrhage (PPH), Incidence of interventional drainage, Incidence of overall postoperative complications, Incidence of POPF-related complications (POPF+DGE+abscess+PPH), Incidence of 3-month mortality, Incidence of reoperation date to postoperative 3 months, Incidence of readmission date to postoperative 3 months

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
2)Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
3)MPD diameter less than 3mm on the left side of the portal vein in preoperative imaging (CT or MRI)
4)Performance status (ECOG scale): 0-1 at the time of enrollment
5)Age: 20 years or older
6)Adequate organ function
A)Leukocyte count: over 2500 mm3, 14000 mm3 or less
B)Hemoglobin: over 9.0 g/dL
C)Platelet count: 100,000 mm3 or less
D)Total Bilirubin: 2.0 mg/dL or less
E)Creatinine: 2.0 mg/dL or less
7)Ability to understand and the willingness to sign a written informed consent
document

Exclude criteria

1)Planned pancreatogastrostomy
2)Laparoscopic
or laparoscope-assisted pancreatoduodenectomy
3)Pancreatic parenchymal atrophy
or calcification due to chronic pancreatitis
4)Neoadjuvant treatment including chemotherapy
or radiotherapy
5)History of upper abdominal surgery
(both of open and laparoscopic) except cholecystectomy
6)Emergency operation
7)Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery
8)Severe ischemic heart disease
9)Severe liver dysfunction
due to liver cirrhosis or active hepatitis
10)Severe respiratory disorder
required oxygen inhalation
11)Chronic renal failure with dialysis
12)Requiring resection of other organs (liver or colon)
during pancreatoduodenectomy
13)Immunosuppressive treatment
14)History of severe hypersensitivity
to PGA felt and fibrin glue
15)Other severe drug allergies
16)Contrast media allergy of both iodine and gadolinium
17)Active duplicate cancer thought
to affect adverse events
18)Severe psychological or neurological disease
19)Drug abuse or alcoholics
20)Planned use of octreotide

Related Information

• Primary Sponsor: Fujii Tsutomu
• Source(s) of Monetary Support: GUNZE LIMITED
• Secondary ID(s): UMIN000029647