Evidence map›Paper›PMID 38955368›Full record

ArticleBMJ open2024

Aggressive hydration with lactated Ringer's solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial.

In Rae Cho, Jin Ho Choi, Joo Kyung Park, Gunn Huh, Sang Hyub Lee, Woo Hyun Paik, Do Hyun Park

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05832047 (Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05832047 phase4completednot on this map

Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial

TypeinterventionalSponsorDo Hyun ParkRan2023 to 2025Enrolled844ConditionsPancreatic DiseaseArmsPlasma solution (4-hour aggressive hydration), Lactated Ringer solution (4-hour aggressive hydration), 8-hour aggressive hydration
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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

7 authors.

In Rae ChoDepartment of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of).
Jin Ho ChoiDepartment of Internal Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Korea (the Republic of).ORCID 0000-0003-2758-1370
Joo Kyung ParkDivision of Gastroenterology, Deparent of Medicine, Samsung Medical Center, Seoul, Korea (the Republic of).
Gunn HuhDepartment of Gastroenterology, Asan Medical Center, Songpa-gu, Seoul, Korea (the Republic of).
Sang Hyub LeeDepartment of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of).ORCID 0000-0003-2174-9726
Woo Hyun PaikDepartment of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of) dhpark@amc.seoul.kr iatrus@hanmail.net.
Do Hyun ParkDepartment of Internal Medicine, Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea (the Republic of) dhpark@amc.seoul.kr iatrus@hanmail.net.ORCID 0000-0002-0270-6969

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEndoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hydration methods. This study investigates the effectiveness of lactated Ringer's solution versus plasma solution in preventing PEP. METHOD AND ANALYSIS: This multicentre, double-blind, randomised controlled trial, will be initiated by the investigator-sponsor, and conducted in three tertiary centres in South Korea. The aim of this study is to assess the effectiveness of hydration in preventing PEP in patients with naïve papillae. It will target patients with naïve papillae, focusing on those at medium to high risk of PEP. Patients aged ≤18 years and those with serious comorbidities, acute/chronic pancreatitis and various other medical conditions will be excluded. Eligible participants will be randomly assigned into two arms in equal numbers: (1) PEP prevention using lactated Ringer's solution and (2) PEP prevention using plasma solution. The primary outcome of this study will be the occurrence of PEP, and secondary outcomes will be additional risk factors and potential adverse events related to ERCP. With a total enrolment of 844 patients, the study will be able to detect significant differences between the intervention arms. ETHICS AND DISSEMINATION: Ethical approval is obtained from each institution (Asan Medical Centre, 2023-0382; Seoul National University Hospital, H-2302-05-1404; Samsung Medical Centre, SMC 2023-02-001-009). All participants provided informed consent following clear explanation of the study procedures. The results of the study will be disseminated in peer-reviewed journals and research conferences. TRIAL REGISTRATION NUMBER: NCT05832047. PROTOCOL VERSION: Ver 4.1 (2023).

Indexed as

Cholangiopancreatography, Endoscopic RetrogradePancreatitisRinger's LactateDouble-Blind MethodFemaleFluid TherapyHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRepublic of KoreaRinger's LactateEndoscopyGASTROENTEROLOGYPancreatic diseaseRandomized Controlled Trial

Identifiers

PMID38955368
PMCPMC11218011

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.