Evidence map›Paper›PMID 35123419›Full record

ArticleBMC cancer2022

The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications.

A van der Veen, L M Schiffmann, E M de Groot, I Bartella, P A de Jong, A S Borggreve, L A A Brosens, D Pinto Dos Santos, H Fuchs, J P Ruurda and 3 more

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

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03896399 (Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.6field-weighted citation impact, top 11% 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.

NCT03896399 nacompletednot on this map

Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications

TypeinterventionalSponsorUMC UtrechtRan2019 to 2022Enrolled22ConditionsEsophageal CancerArmsLaparoscopic ischemic conditioning followed by esophagectomy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Ulcer Scarring in the Gastric Conduit Is a Risk Factor for Anastomotic Leakage After Esophagectomy for Esophageal Cancer.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2023
    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

13 authors at 4 institutions in 2 countries.

A van der Veen *Department of Surgery, University Medical Center Utrecht, POBOX 85500, 3508 GA, Utrecht, The Netherlands.
L M Schiffmann *Department of General, Visceral, Cancer and Transplant Surgery, Faculty of Medicine, University of Cologne, Cologne, Germany.
E M de GrootDepartment of Surgery, University Medical Center Utrecht, POBOX 85500, 3508 GA, Utrecht, The Netherlands. e.m.degroot-26@umcutrecht.nl.
I BartellaDepartment of General, Visceral, Cancer and Transplant Surgery, Faculty of Medicine, University of Cologne, Cologne, Germany.
P A de JongDepartment of Radiology, Division of Imaging and Oncology, University Medical Center Utrecht and Utrecht University, Utrecht, The Netherlands.
A S BorggreveDepartment of Surgery, University Medical Center Utrecht, POBOX 85500, 3508 GA, Utrecht, The Netherlands.
L A A BrosensDepartment of Pathology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
D Pinto Dos SantosInstitute of Diagnostic and Interventional Radiology, University of Cologne, Medical Faculty and University Hospital Cologne, Cologne, Germany.
H FuchsDepartment of General, Visceral, Cancer and Transplant Surgery, Faculty of Medicine, University of Cologne, Cologne, Germany.
J P RuurdaDepartment of Surgery, University Medical Center Utrecht, POBOX 85500, 3508 GA, Utrecht, The Netherlands.
C J BrunsDepartment of General, Visceral, Cancer and Transplant Surgery, Faculty of Medicine, University of Cologne, Cologne, Germany.
R van Hillegersberg *Department of Surgery, University Medical Center Utrecht, POBOX 85500, 3508 GA, Utrecht, The Netherlands. r.vanhillegersberg@umcutrecht.nl.
W Schröder *Department of General, Visceral, Cancer and Transplant Surgery, Faculty of Medicine, University of Cologne, Cologne, Germany.
University Medical Center Utrecht · NLUniversity of Cologne · DEUtrecht University · NLUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnastomotic leakage is the most important surgical complication following esophagectomy. A major cause of leakage is ischemia of the gastric tube that is used for reconstruction of the gastrointestinal tract. Generalized cardiovascular disease, expressed by calcifications of the aorta and celiac axis stenosis on a pre-operative CT scan, is associated with an increased risk of anastomotic leakage. Laparoscopic ischemic conditioning (ISCON) aims to redistribute blood flow and increase perfusion at the anastomotic site by occluding the left gastric, left gastroepiploic and short gastric arteries prior to esophagectomy. This study aims to assess the safety and feasibility of laparoscopic ISCON in selected patients with esophageal cancer and concomitant arterial calcifications.

methodsIn this prospective single-arm safety and feasibility trial based upon the IDEAL recommendations for surgical innovation, a total of 20 patients will be included recruited in 2 European high-volume centers for esophageal cancer surgery. Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with "major calcifications" of the thoracic aorta accordingly to the Uniform Calcification Score (UCS) or a stenosis of the celiac axis accordingly to the modified North American Symptomatic Carotid Endarterectomy Trial (NASCET) score on preoperative CT scan, who are planned to undergo esophagectomy are eligible for inclusion. The primary outcome variables are complications grade 2 and higher (Clavien-Dindo classification) occurring during or after laparoscopic ISCON and before esophagectomy. Secondary outcomes include intra- and postoperative complications of esophagectomy and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography. DISCUSSION: We hypothesize that in selected patients with impaired vascularization of the gastric tube, laparoscopic ISCON is feasible and can be safely performed 12-18 days prior to esophagectomy. Depending on the results, a randomized controlled trial will be needed to investigate whether ISCON leads to a lower percentage and less severe course of anastomotic leakage in selected patients.

trial registrationClinicaltrials.gov, NCT03896399 . Registered 4 January 2019.

Indexed as

AdolescentAdultAnastomotic LeakEsophageal NeoplasmsEsophagectomyFeasibility StudiesFemaleGastric ArteryHumansIschemic PreconditioningLaparoscopyMaleMiddle AgedProspective StudiesTreatment OutcomeVascular CalcificationEsophagectomyIschemic preconditioningISCON

Identifiers

PMID35123419
PMCPMC8817569
OpenAlexW4210814639

What OpenQuestion holds

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LicenceCC BY
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.