Evidence map›Paper›PMID 31758329›Full record

Trial reportJournal of gastroenterology2020

Continuous regional arterial infusion versus intravenous administration of the protease inhibitor nafamostat mesilate for predicted severe acute pancreatitis: a multicenter, randomized, open-label, phase 2 trial.

Morihisa Hirota, Tooru Shimosegawa, Katsuya Kitamura, Kazunori Takeda, Yoshifumi Takeyama, Toshihiko Mayumi, Tetsuhide Ito, Mamoru Takenaka, Eisuke Iwasaki, Hirotaka Sawano and 19 more

Open access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
7.3field-weighted citation impact, top 2% of its field
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

23 citing papers in PubMed, 43 citations in OpenAlex.

  1. Article
  2. Article
  3. Regional Arterial Infusion of Nafamostat Mesylate and Lidocaine in the Treatment of Cerulein-Induced Acute Pancreatitis in Rats.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025
    Article
  4. Acute Pancreatitis Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023
    Article
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  13. Review
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  17. Experimental Pharmacotherapy for COVID-19: The Latest Advances.Journal of experimental pharmacology · 2021
    Review
  18. Review
  19. Immune response in COVID-19: A review.Journal of infection and public health · 2020
    Review
  20. 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

29 authors at 20 institutions in 1 country.

Morihisa HirotaDivision of Gastroenterology and Hepatology, Tohoku Medical and Pharmaceutical University, 1-15-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, 9838536, Japan. morihirota7373@gmail.com.ORCID http://orcid.org/0000-0001-5682-0911
Tooru ShimosegawaDepartment of Gastroenterology, South Miyagi Medical Center, 28-1 Nishi, Ohgawara, Miyagi, 9891253, Japan.
Katsuya KitamuraDivision of Gastroenterology, Department of Medicine, Showa University School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 1428666, Japan.
Kazunori TakedaMiyagi Branch, Health Insurance Claims Review & Reimbursement Services, 5-1-27, Tsutsujigaoka, Miyagino-ku, Sendai, Miyagi, 9838504, Japan.
Yoshifumi TakeyamaDepartment of Surgery, Kindai University, Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 5898511, Japan.
Toshihiko MayumiDepartment of Emergency Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, 8078555, Japan.
Tetsuhide ItoDepartment of Gastroenterology and Hepatology, International University of Health and Welfare Graduate School of Medicine, Neuroendocrine Tumor Center, Fukuoka Sanno Hospital, 3-6-45, Momochihama, Sawara-ku, Fukuoka, 8140001, Japan.
Mamoru TakenakaDepartment of Gastroenterology and Hepatology, Kindai University, Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 5898511, Japan.
Eisuke IwasakiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 1608582, Japan.
Hirotaka SawanoSenri Critical Care Medical Center, Osaka Saiseikai Senri Hospital, 1-1-6, Tsukumodai, Suita, Osaka, 5650862, Japan.
Etsuji IshidaDepartment of Gastroenterology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, 7108602, Japan.
Shin MiuraDivision of Gastroenterology, Tohoku University Graduate School of Medicine, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan.
Atsushi MasamuneDivision of Gastroenterology, Tohoku University Graduate School of Medicine, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan.
Yousuke NakaiDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Akira MitoroThird Department of Internal Medicine, Nara Medical University, 840, Shijo-cho, Kashihara, Nara, 6348522, Japan.
Hiroyuki MaguchiCenter for Gastroenterology, Teine-keijinkai Hospital, 1-12-1-40, Maeda, Teine-ku, Sapporo, 0068555, Japan.
Kenji KimuraDepartment of Gastroenterology, National Hospital Organization Sendai Medical Center, 2-11-12, Miyagino, Miyagino-ku, Sendai, Miyagi, 9838520, Japan.
Tsuyoshi SanukiDepartment of Gastroenterology, Kita-Harima Medical Center, 926-250, Ichiba-cho, Ono, Hyogo, 6751392, Japan.
Tetsuya ItoDepartment of Internal Medicine, Gastroenterology, Shinshu University Hospital, 3-1-1, Akashi, Matsumoto, Nagano, 3908621, Japan.
Hiroki HaradomeDepartment of Radiological Advanced Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 2520375, Japan.
Kazuto KozakaDepartment of Radiology, Kanazawa University, Graduate School of Medical Sciences, 13-1, Takaramachi, Kanazawa, Ishikawa, 9208641, Japan.
Toshifumi GabataDepartment of Radiology, Kanazawa University, Graduate School of Medical Sciences, 13-1, Takaramachi, Kanazawa, Ishikawa, 9208641, Japan.
Keisho KataokaDepartment of Gastroenterology, Otsu Municipal Hospital, 2-9-9, Motomiya, Otsu, Shiga, 5200804, Japan.
Masahiko HirotaDepartment of Surgery, Kumamoto Regional Medical Center, 5-16-10, Honjou, Chuou-ku, Kumamoto, 8600811, Japan.
Shuji IsajiDepartment of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Graduate School of Medicine, 2-174, Edobashi, Tsu, Mie, 5148507, Japan.
Ryoji NakamuraInter Scientific Research Co., Ltd, 3-14-1, Higashinakano, Nakano-ku, Tokyo, 1640003, Japan.
Koki YamagiwaDepartment of Development Promotion, Clinical Research, Innovation, Education Center, Tohoku University Hospital, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan.
Chie KayabaDepartment of Development Promotion, Clinical Research, Innovation, Education Center, Tohoku University Hospital, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan.
Koji IkedaDepartment of Development Promotion, Clinical Research, Innovation, Education Center, Tohoku University Hospital, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan.
Tohoku University Hospital · JPFukuoka International University · JPKanazawa University · JPKindai University · JPTohoku Medical and Pharmaceutical University Hospital · JPTohoku University · JPKeio University · JPKitasato University · JPKurashiki Central Hospital · JPMie University · JPNara Medical University · JPOtsu Municipal Hospital · JPSaiseikaisenri Hospital · JPSendai Medical Center · JPShowa University · JPTeine Keijinkai Hospital · JPThe University of Tokyo · JPTochigi Medical Center · JPTokyo-Kita Medical Center · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

Japan Agency for Medical Research and Development JP16lk0103015Japan Agency for Medical Research and Development (JP) JP15lk0103015
6 · The paper itself

Abstract

backgroundContinuous regional arterial infusion (CRAI) of protease inhibitor nafamostat mesilate (NM) is used in the context of predicted severe acute pancreatitis (SAP) to prevent the development of pancreatic necrosis. Although this therapy is well known in Japan, its efficacy and safety remain unclear.

methodsThis investigator-initiated and -driven, multicenter, open-label, randomized, controlled trial (UMIN000020868) enrolled 39 patients with predicted SAP and low enhancement of the pancreatic parenchyma on computed tomography (CT). Twenty patients were assigned to the CRAI group, while 19 served as controls and were administered NM at the same dose intravenously (IV group). The primary endpoint was the development of pancreatic necrosis as determined by CT on Day 14, judged by blinded central review.

resultsThere was no difference between the CRAI and IV groups regarding the percentages of participants who developed pancreatic necrosis (more than 1/3 of the pancreas: 25.0%, range 8.7-49.1% vs. 15.8%, range 3.4-39.6%, respectively, P = 0.694; more than 2/3 of the pancreas: 20%, range 5.7-43.7% vs. 5.3%, range 0.1-26.0%, respectively, P = 0.341). The early analgesic effect was evaluated based on 24-h cumulative fentanyl consumption and additional administration by intravenous patient-controlled analgesia. The results showed that the CRAI group used significantly less analgesic. There were two adverse events related to CRAI, namely bleeding and splenic infarction.

conclusionsCRAI with NM did not inhibit the development of pancreatic necrosis although early analgesic effect of CRAI was superior to that of IV. Less-invasive IV therapy can be considered a viable alternative to CRAI therapy.

Indexed as

Administration, IntravenousAdultAgedBenzamidinesFemaleGuanidinesHumansInfusions, Intra-ArterialJapanMaleMiddle AgedPancreatitisPancreatitis, Acute NecrotizingProtease InhibitorsSeverity of Illness IndexTomography, X-Ray ComputedBenzamidinesGuanidinesnafamostatProtease InhibitorsAcute pancreatitisAnalgesicContinuous regional arterial infusionPancreatic necrosisProtease inhibitor

Identifiers

PMID31758329
PMCPMC7026212
OpenAlexW2990815134

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Registered trials

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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.