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

Phase 3

Active, not recruiting

• Conditions: Disease of Pancreatic or Periampullary Lesions
• Interventions: Drug: PGA felt reinforcement

• Registration Number: NCT03331718
• Lead Sponsor: University of Toyama

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Study Start: 2018-10-10
• Primary Completion: 2021-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 514

Inclusion Criteria

1. Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
2. Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
3. MPD diameter ≤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: ≥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
7. Ability to understand and the willingness to sign a written informed consent document

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Exclusion 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGA felt reinforcement	PGA felt reinforcement	In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.

Primary Outcome Measures

Name	Time	Method
Incidence of a clinically relevant POPF (ISGPS grade B/C)	within 3 months after surgery	Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF

Secondary Outcome Measures

Name	Time	Method
Length of drain placement	within 3 months after surgery	Number of days from operation date to drain removal date (the peripancreatic drain to be removed last)
Length of the hospital stay	within 3 months after surgery	Number of days from operation date to discharge date
Incidence of POPF by each suturing method to approximate the pancreas and the jejunum	within 3 months after surgery	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)
Incidence of overall POPF (Biochemical leak, grade B, and C)	within 3 months after surgery	Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria
Incidence of overall postoperative complications	within 3 months after surgery	Incidence of overall postoperative complications, according to Clavien-Dindo classification
Incidence of POPF-related complications (POPF+DGE+abscess+PPH)	within 3 months after surgery	Incidence of cases in whom one of 3), 5), 6) or 7) occurred
Incidence of 3-month mortality	within 3 months after surgery	Incidence of surgery-related deaths from operation date to postoperative 3 months
Incidence of postpancreatectomy hemorrhage (PPH)	within 3 months after surgery	Incidence of overall PPH, according to the ISGPS criteria
Incidence of reoperation	within 3 months after surgery	Incidence of reoperation from operation date to postoperative 3 months
Incidence of readmission	within 3 months after surgery	Incidence of readmission from operation date to postoperative 3 months
Incidence of delayed gastric emptying (DGE)	within 3 months after surgery	Incidence of overall DGE, according to the ISGPS criteria
Incidence of intraabdominal abscess	within 3 months after surgery	Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification
Incidence of interventional drainage	within 3 months after surgery	Incidence of additional drainage percutaneously or endoscopically

Trial Locations

Locations (1)

University of Toyama; 🇯🇵 Toyama, Japan