Evidence map›Paper›PMID 31399139›Full record

ArticleTrials2019

The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea.

Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03331718 (PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03331718 phase3completednot on this map

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

TypeinterventionalSponsorUniversity of ToyamaRan2018 to 2022Enrolled514ConditionsDisease of Pancreatic or Periampullary LesionsArmsPGA felt reinforcement
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Kazuto ShibuyaDepartment of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Jin-Young JangDepartment of Surgery, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sohei SatoiDepartment of Surgery, Kansai Medical University, Hirakata, Japan.
Masayuki ShoDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Suguru YamadaDepartment of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
Manabu KawaiSecond Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Hongbeom KimDepartment of Surgery, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Song Cheol KimDepartment of Surgery, Asan Medical Centre, Seoul, Republic of Korea.
Jin Seok HeoDepartment of Surgery, Samsung Medical Centre, Seoul, Republic of Korea.
Yoo-Seok YoonDepartment of Surgery, Seoul National University Bundang Hospital, Seoul, Republic of Korea.
Joon Seong ParkDepartment of Surgery, Gangnam Severance Hospital, Seoul, Republic of Korea.
Ho Kyoung HwangDepartment of Surgery, Severance Hospital, Seoul, Republic of Korea.
Isaku YoshiokaDepartment of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Toshio ShimokawaClinical Study Support Centre, Wakayama Medical University, Wakayama, Japan.
Hiroki YamaueSecond Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Tsutomu FujiiDepartment of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan. fjt@med.u-toyama.ac.jp.

Funding

CSRD VA 1
6 · The paper itself

Abstract

backgroundPartial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, the technique has not yet been standardized. We devised a new method using double-coated polyglycolic acid felt after pancreaticojejunostomy. The aim of the PLANET-PJ trial is to evaluate the superiority of polyglycolic acid felt reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing partial pancreatoduodenectomy to previous anastomosis methods.

methodsPatients diagnosed with pancreatic or periampullary lesions in whom it is judged that the main pancreatic duct diameter was 3 mm or less on the left side of the portal vein without pancreatic parenchymal atrophy due to obstructive pancreatitis are considered eligible for inclusion. This study is designed as a multicentre randomized phase III trial in Japan and the Republic of Korea. Eligible patients will be centrally randomized to either group A (polyglycolic acid felt reinforcement) or group B (control). In total, 514 patients will be randomized in 31 high-volume centres in Japan and Republic of Korea. The primary endpoint is the incidence of POPF (International Study Group of Pancreatic Surgery grade B/C). DISCUSSION: The PLANET-PJ trial evaluates the efficacy of a new method using double-coated polyglycolic acid felt reinforcement for preventing POPF after pancreaticojejunostomy. This new method may reduce POPF.

trial registrationClinicalTrials.gov, NCT03331718 . University Hospital Medical Information Network Clinical Trials Registry, UMIN000029647. Registered on 30 November 2017. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874.

Indexed as

Pancreatic DuctsPancreatic FistulaPancreaticoduodenectomyPancreaticojejunostomyPolyglycolic AcidPostoperative ComplicationsClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicPolyglycolic AcidInternational multicentre studyPancreaticojejunostomyPancreatoduodenectomyPolyglycolic acid feltPostoperative pancreatic fistula

Identifiers

PMID31399139
PMCPMC6688253

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.