PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)

Conditions
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Disease of Pancreatic or Periampullary Lesions

Intervention / Treatment
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* Drug: PGA felt reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy Planned pancreaticojejunostomy including duct-to-mucosa anastomosis MPD diameter ≤3mm on the left side of the portal vein in preoperative imaging (CT or MRI) Performance status (ECOG scale): 0-1 at the time of enrollment Age: 20 years or older Adequate organ function A) Leukocyte count: ≥2500 mm3, ≤14000 mm3 B) Hemoglobin: ≥9.0 g/dL C) Platelet count: ≥100,000 mm3 D) Total Bilirubin: ≤2.0 mg/dL (not apply to cases with obstructive jaundice) E) Creatinine: ≤2.0 mg/dL Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Planned pancreatogastrostomy Laparoscopic or laparoscope-assisted pancreatoduodenectomy Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis Neoadjuvant treatment including chemotherapy or radiotherapy History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy Emergency operation Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery Severe ischemic heart disease Severe liver dysfunction due to liver cirrhosis or active hepatitis Severe respiratory disorder required oxygen inhalation Chronic renal failure with dialysis Requiring resection of other organs (liver or colon) during pancreatoduodenectomy Immunosuppressive treatment History of severe hypersensitivity to PGA felt and fibrin glue Other severe drug allergies Contrast media allergy of both iodine and gadolinium Active duplicate cancer thought to affect adverse events Severe psychological or neurological disease Drug abuse or alcoholics Planned use of octreotide

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual. | |
| Active Comparator: PGA felt reinforcement<br>In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate. | Drug: PGA felt reinforcement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of drain placement | Number of days from operation date to drain removal date (the peripancreatic drain to be removed last) | within 3 months after surgery | 
| Length of the hospital stay | Number of days from operation date to discharge date | 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 | 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) | within 3 months after surgery | 
| Incidence of delayed gastric emptying (DGE) | Incidence of overall DGE, according to the ISGPS criteria | 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 | within 3 months after surgery | 
| Incidence of postpancreatectomy hemorrhage (PPH) | Incidence of overall PPH, according to the ISGPS criteria | within 3 months after surgery | 
| Incidence of interventional drainage | Incidence of additional drainage percutaneously or endoscopically | within 3 months after surgery | 
| Incidence of overall postoperative complications | Incidence of overall postoperative complications, according to Clavien-Dindo classification | 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 | within 3 months after surgery | 
| Incidence of 3-month mortality | Incidence of surgery-related deaths from operation date to postoperative 3 months | within 3 months after surgery | 
| Incidence of reoperation | Incidence of reoperation from operation date to postoperative 3 months | within 3 months after surgery | 
| Incidence of readmission | Incidence of readmission from operation date to postoperative 3 months | within 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatoduodenectomy, pancreaticojejunostomy, polyglycolic acid, Neoveil, pancreatic fistula, pancreas