Evidence map›Paper›PMID 39415231›Full record

ArticleBMC surgery2024

The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan.

Hayato Baba, Atsushi Oba, Kimitaka Tanaka, Takayuki Miura, Daisuke Ban, Motonori Edanami, Yoshiya Ishikawa, Katsuhisa Ohgi, Haruyoshi Tanaka, Ryuta Shintakuya and 34 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
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

44 authors.

Hayato BabaDivision of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.
Atsushi ObaDivision of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.
Kimitaka TanakaDepartment of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, North 15, West 7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
Takayuki MiuraDepartment of Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-Machi, Aoba-Ku, Sendai, Miyagi, 980-8575, Japan.
Daisuke BanDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo, 104-0045, Japan.
Motonori EdanamiDepartments of Surgery, Keio University School of Medicine, Japan. 35 Shinanomachi, Shinjuku-Ku, TokyoTokyo, 162-8666, Japan.
Yoshiya IshikawaDepartment of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan.
Katsuhisa OhgiDivision of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007 , Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Haruyoshi TanakaDepartment of Surgery, Nagoya University Hospital, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8560, Japan.
Ryuta ShintakuyaDepartment of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-Ku, Hiroshima, Hiroshima, 734-8551, Japan.
Naoki IkenagaDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, Fukuoka, 812-8582, Japan.
Tetsuya IjichiDepartment of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1, Sakuragaoka, Kagoshima, Kagoshima, Japan.
Yoshitaka KiyaDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-Ku, Tokyo, 160-0023, Japan.
Ryo MuranushiDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630 , Sugitani, Toyama, Toyama, 930-0194, Japan.
So YamakiDepartment of Pancreatobiliary Surgery, Kansai Medical University, 2-5-1 Shin-Machi, Hirakata, Osaka, 573-1010, Japan.
Naoki MiyazakiDivision of Clinical Research Planning and Strategy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.
Shintaro TakeuchiDepartment of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, North 15, West 7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
Shuichi AokiDepartment of Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-Machi, Aoba-Ku, Sendai, Miyagi, 980-8575, Japan.
Takahiro MizuiDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo, 104-0045, Japan.
Masayuki TanakaDepartments of Surgery, Keio University School of Medicine, Japan. 35 Shinanomachi, Shinjuku-Ku, TokyoTokyo, 162-8666, Japan.
Hiroki UedaDepartment of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan.
Hideyuki DeiDivision of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007 , Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Hideki TakamiDepartment of Surgery, Nagoya University Hospital, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8560, Japan.
Kenjiro OkadaDepartment of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-Ku, Hiroshima, Hiroshima, 734-8551, Japan.
Kohei NakataDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, Fukuoka, 812-8582, Japan.
Yuko MatakiDepartment of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1, Sakuragaoka, Kagoshima, Kagoshima, Japan.
Hiroaki OsakabeDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-Ku, Tokyo, 160-0023, Japan.
Kazuto ShibuyaDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630 , Sugitani, Toyama, Toyama, 930-0194, Japan.
Daisuke HashimotoDepartment of Pancreatobiliary Surgery, Kansai Medical University, 2-5-1 Shin-Machi, Hirakata, Osaka, 573-1010, Japan.
Yosuke InoueDivision of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.
Satoshi HiranoDepartment of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, North 15, West 7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
Michiaki UnnoDepartment of Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-Machi, Aoba-Ku, Sendai, Miyagi, 980-8575, Japan.
Minoru EsakiDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo, 104-0045, Japan.
Minoru KitagoDepartments of Surgery, Keio University School of Medicine, Japan. 35 Shinanomachi, Shinjuku-Ku, TokyoTokyo, 162-8666, Japan.
Keiichi AkahoshiDepartment of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan.
Teiichi SugiuraDivision of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007 , Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Tomoki EbataDepartment of Surgery, Nagoya University Hospital, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8560, Japan.
Kenichiro UemuraDepartment of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-Ku, Hiroshima, Hiroshima, 734-8551, Japan.
Masafumi NakamuraDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, Fukuoka, 812-8582, Japan.
Takao OtsukaDepartment of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1, Sakuragaoka, Kagoshima, Kagoshima, Japan.
Yuichi NagakawaDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-Ku, Tokyo, 160-0023, Japan.
Tsutomu FujiiDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630 , Sugitani, Toyama, Toyama, 930-0194, Japan.
Sohei SatoiDepartment of Pancreatobiliary Surgery, Kansai Medical University, 2-5-1 Shin-Machi, Hirakata, Osaka, 573-1010, Japan.
Yu TakahashiDivision of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan. yu.takahashi@jfcr.or.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP.

methodsThis multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C). DISCUSSION: The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety.

trial registrationThis trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).

Indexed as

Fibrin Tissue AdhesivePancreatectomyPancreatic FistulaPolyglycolic AcidPostoperative ComplicationsSurgical MeshAdultFemaleHumansJapanLaparoscopyMaleMiddle AgedMulticenter Studies as TopicPancreatic NeoplasmsRandomized Controlled Trials as TopicFibrin Tissue AdhesivePolyglycolic AcidTissue AdhesivesDistal pancreatectomyFibrin glueMinimally invasive surgeryPancreatic fistulaPolyglycolic acid mesh

Identifiers

PMID39415231
PMCPMC11481437

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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.