Evidence map›Paper›PMID 25609264›Full record

Trial reportNutrition journal2015

Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients.

Cheng-Jen Ma, Jin-Ming Wu, Hsiang-Lin Tsai, Ching-Wen Huang, Chien-Yu Lu, Li-Chu Sun, Ying-Ling Shih, Chao-Wen Chen, Jui-Fen Chuang, Ming-Hsun Wu and 3 more

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

Trial report in Nutrition journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00798447 (A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.), which is not on this map. Cited by 27 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 9 pooled it
3.4field-weighted citation impact, top 8% 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.

NCT00798447 phase3completednot on this map

A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.

TypeinterventionalSponsorB. Braun Melsungen AGRan2008 to 2010Enrolled100ConditionsGI CancerArmsMLF 541, Lipofundin MCT
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 9 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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  8. Effect of Perioperative Nutritional Supplementation on Postoperative Complications-Systematic Review and Meta-Analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
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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

13 authors at 3 institutions in 1 country.

Cheng-Jen Ma
Jin-Ming Wu
Hsiang-Lin Tsai
Ching-Wen Huang
Chien-Yu Lu
Li-Chu Sun
Ying-Ling Shih
Chao-Wen Chen
Jui-Fen Chuang
Ming-Hsun Wu
Ming-Yang Wang
Ming-Tsan LinDivision of Gastroenterology and General Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No, 100 Tzyou 1st Road, Kaohsiung 807, Taiwan. linmt@ntu.edu.tw.
Jaw-Yuan Wang
Kaohsiung Medical University Chung-Ho Memorial Hospital · TWKaohsiung Medical University · TWNational Taiwan University Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA lipid emulsion composed of soybean oil (long-chain triglycerides, LCT), medium-chain triglycerides (MCT) and n-3 poly-unsaturated fatty acids (PUFAs) was evaluated for immune-modulation efficacy, safety, and tolerance in patients undergoing major surgery for gastric and colorectal cancer.

methodsIn a prospective, randomized, double-blind study, 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group, receiving the n-3 PUFAs enriched intravenous fat emulsion (IVFE), or the control group, receiving a lipid emulsion comprised of soybean oil and MCTs (0.8 - 1.5 g · kg-1 · day-1) as part of total parenteral nutrition (TPN) regimen from surgery (day -1) up to post-operative day 7. Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1, 3, and 7. Adverse events were documented daily and compared between the groups.

resultsPro-inflammatory markers, laboratory parameters, and adverse events did not differ prominently between the 2 groups, with the exception of net changes (day 7 minus day -1) of free fatty acids (FFAs), triglyceride, and high-density lipoprotein (HDL). Net decrease of FFAs was remarkably higher in the study group, while the net increase of triglyceride and decrease of HDL was significantly lower.

conclusionsThe n-3 PUFA-enriched IVFE showed improvements in lipid metabolism. In respect of efficacy, safety and tolerance both IVFE were comparable. In patients with severe stress, there is an inflammation-attenuating effect of n-3 PUFAs. Further, adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients.

trial registrationUS ClinicalTrials.gov NCT00798447.

Indexed as

AgedColorectal NeoplasmsDouble-Blind MethodFat Emulsions, IntravenousFatty Acids, Omega-3FemaleHumansLipidsMaleMiddle AgedPostoperative CareProspective StudiesStomach NeoplasmsFat Emulsions, IntravenousFatty Acids, Omega-3Lipids

Identifiers

PMID25609264
PMCPMC4326201
OpenAlexW2127188645

What OpenQuestion holds

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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.