PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 514
- 试验地点
- 2
- 主要终点
- Incidence of a clinically relevant POPF (ISGPS grade B/C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PGA felt reinforcement
In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.
干预措施: PGA felt reinforcement (Drug)
结局指标
主要结局
Incidence of a clinically relevant POPF (ISGPS grade B/C)
时间窗: 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
次要结局
- Length of drain placement(within 3 months after surgery)
- Length of the hospital stay(within 3 months after surgery)
- Incidence of postpancreatectomy hemorrhage (PPH)(within 3 months after surgery)
- Incidence of POPF by each suturing method to approximate the pancreas and the jejunum(within 3 months after surgery)
- Incidence of overall POPF (Biochemical leak, grade B, and C)(within 3 months after surgery)
- Incidence of overall postoperative complications(within 3 months after surgery)
- Incidence of POPF-related complications (POPF+DGE+abscess+PPH)(within 3 months after surgery)
- Incidence of 3-month mortality(within 3 months after surgery)
- Incidence of reoperation(within 3 months after surgery)
- Incidence of readmission(within 3 months after surgery)
- Incidence of delayed gastric emptying (DGE)(within 3 months after surgery)
- Incidence of intraabdominal abscess(within 3 months after surgery)
- Incidence of interventional drainage(within 3 months after surgery)
研究者
Tsutomu Fujii
MD, PhD, FACS
University of Toyama