Evidence map›Paper›PMID 34530885›Full record

ArticleTrials2021

ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial.

Ken-Ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-Ichi Yamashita and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04600063 (Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 46% 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.

NCT04600063 naunknown statusnot on this map

Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer

TypeinterventionalSponsorWakayama Medical UniversityRan2020 to 2025Enrolled100ConditionsResectable Pancreatic Body/Tail CarcinomaArmsIsolation procedure (RAMPS procedure), Conventional procedure
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

26 authors at 11 institutions in 1 country.

Ken-Ichi OkadaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Manabu KawaiSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Seiko HironoSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Masayuki ShoDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Masaji TaniDepartment of Surgery, Shiga University of Medical Science, Ōtsu, Japan.
Ippei MatsumotoDepartment of Surgery, Kindai University Hospital, Osaka, Japan.
Suguru YamadaDepartment of Surgery, Nagoya Central Hospital, Nagoya, Japan.
Ryosuke AmanoDepartment of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Hirochika ToyamaDepartment of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.
Yo-Ichi YamashitaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Takeshi GochoDepartment of Surgery, Jikei University School of Medicine, Tokyo, Japan.
Kazuto ShibuyaDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan.
Minako NagaiDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Hiromitsu MaehiraDepartment of Surgery, Shiga University of Medical Science, Ōtsu, Japan.
Keiko KameiDepartment of Surgery, Kindai University Hospital, Osaka, Japan.
Go OhiraDepartment of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Yoshihiro ShiraiDepartment of Surgery, Jikei University School of Medicine, Tokyo, Japan.
Hideki TakamiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Nana KimuraDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan.
Takumi FukumotoDepartment of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Yasuhiro KoderaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Akimasa NakaoDepartment of Surgery, Nagoya Central Hospital, Nagoya, Japan.
Toshio ShimokawaClinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Masahiro KatsudaClinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Hiroki YamaueSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan. yamaue-h@wakayama-med.ac.jp.ORCID http://orcid.org/0000-0002-6982-3457
Wakayama Medical University · JPJikei University School of Medicine · JPKindai University Hospital · JPKobe University · JPKumamoto University · JPNagoya Central Hospital · JPNagoya University · JPNara Medical University · JPOsaka City University · JPShiga University of Medical Science · JPUniversity of Toyama · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissected, followed by median-to-left retroperitoneal dissection. This procedure has the potential to isolate blood and lymphatic flow to the area of the pancreatic body/tail and the spleen to be excised. This is achieved by division of the inflow artery, transection of the pancreas, and then division of the outflow vein in the early phases of surgery. In cases of pancreatic ductal adenocarcinoma (PDAC), the procedure has been shown to decrease intraoperative blood loss and increase R0 resection rate by complete clearance of the lymph nodes. This trial investigates whether the isolation procedure can prolong the survival of patients with pancreatic ductal adenocarcinoma who undergo distal pancreatosplenectomy (DPS) compared with those that undergo the conventional approach. METHODS/

designPatients with PDAC scheduled to undergo DPS are randomized before surgery to undergo either a conventional procedure (arm A) or to undergo the isolation procedure (arm B). In arm A, the pancreatic body, tail, and spleen are mobilized, followed by removal of the regional lymph nodes. The splenic vein is transected at the end of the procedure. The timing of division of the splenic artery (SA) is not restricted. In arm B, regional lymph nodes are dissected, then we transect the root of the SA, the pancreas, then the splenic vein. At the end of the procedure, the pancreatic body/tail and spleen are mobilized and removed. In total, 100 patients from multiple Japanese high-volume centers will be randomized. The primary endpoint is 2-year recurrence-free survival by intention-to-treat analysis. Secondary endpoints include intraoperative blood loss, R0 resection rate, and overall survival. DISCUSSION: If this trial shows that the isolation procedures can improve survival with a similar R0 rate and with a similar number of lymph node dissections to the conventional procedure, the isolation procedure is expected to become a standard procedure during DPS for PDAC. Conversely, if there were no significant differences in endpoints between the groups, it would demonstrate justification of either procedure from surgical and oncological points of view.

trial registrationUMIN Clinical Trials Registry UMIN000041381 . Registered on 10 August 2020. ClinicalTrials.gov NCT04600063 . Registered on 22 October 2020.

Indexed as

Carcinoma, Pancreatic DuctalPancreatic NeoplasmsHumansLymph Node ExcisionPancreasPancreatectomyRandomized Controlled Trials as TopicDistal pancreatectomyDistal pancreatosplenectomyIsolationRadical antegrade modular pancreatosplenectomy

Identifiers

PMID34530885
PMCPMC8447574
OpenAlexW3200775325

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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.