Evidence map›Paper›PMID 26223668›Full record

Observational studyDer Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen2015

[Lymph node dissection after primary surgery and neoadjuvant radiochemotherapy of rectal cancer. Interim analysis of a multicenter prospective observational study (OCUM)].

M E Kreis, C A Maurer, R Ruppert, H Ptok, J Strassburg, T Junginger, S Merkel, P Hermanek

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01325649 (Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 47% 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.

NCT01325649 completednot on this map

Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma

TypeobservationalSponsorJohannes Gutenberg University MainzRan2009 to 2016Enrolled1,051ConditionsRectal Cancer Stage II, Rectal Cancer Stage IIIArmstotal mesorectal excision / long course radiochemotherapy, long course 5-FU bases radiochemotherapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Accuracy of Various Lymph Node Staging Criteria in Rectal Cancer with Magnetic Resonance Imaging.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2018
    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

8 authors at 7 institutions in 2 countries.

M E KreisKlinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200, Berlin, Deutschland. martin.kreis@charite.de.
C A MaurerHospital Liestal, Liestal, Schweiz.
R RuppertKlinikum München Neuperlach, München, Deutschland.
H PtokCarl-Thiem-Klinikum, Cottbus, Deutschland.
J StrassburgVivantes Klinikum Friedrichshain, Berlin, Deutschland.
T JungingerUniversitätsmedizin Mainz, Mainz, Deutschland.
S MerkelChirurgische Klinik, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland.
P HermanekChirurgische Klinik, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland.
Friedrich-Alexander-Universität Erlangen-Nürnberg · DECarl-Thiem-Klinikum Cottbus · DECharité - Universitätsmedizin Berlin · DEJohannes Gutenberg University Mainz · DEKlinikum im Friedrichshain · DEMittal hospital · INMünchen Klinik Neuperlach · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe OCUM trial (NCT01325649) aims to clarify whether low rates of local recurrence are also achieved when the indications for neoadjuvant radiochemotherapy are not based on the clinical TNM staging but on preoperative magnetic resonance imaging with measurement of the tumor distance to the circumferential resection margin. In this interim analysis the lymph node status in OCUM patients was investigated as a surrogate parameter for quality of surgery and histopathological work-up. MATERIAL AND

methodsUntil now a total of 560 patients have been included in this study. Total mesorectal excision (TME) without pretreatment was undertaken in 338 patients (60.4 %) and neoadjuvant radiochemotherapy was administered in 222 (39.6 %) patients. The histological work-up was performed according to the guidelines of the German Association of Pathologists. Data are given as median values and ranges in brackets.

resultsThe lymph node yield was 24 (7-79) in 338 patients undergoing primary TME surgery without pretreatment, while 20 (3-56) lymph nodes were identified in patients after neoadjuvant radiochemotherapy (p = 0.001). A minimum of 12 lymph nodes were analyzed in 335 out of 338 patients (99.1 %) and in 209 out of 222 patients (94.1 %) following neoadjuvant radiochemotherapy (p = 0.001). Lymph node metastasis was identified (p = 0.362) in 116 out of 338 patients without pretreatment (34.3 %) and in 71 out of 222 patients after neoadjuvant radiochemotherapy (32.0 %). Patient age did not influence the number of identified lymph nodes or rate of lymph node metastasis.

conclusionIn this trial the number of identified lymph nodes suggests that the quality of surgery and histopathological work-up were adequate compared to the standards defined by national guidelines. Neoadjuvant radiochemotherapy led to a reduced lymph node yield compared to surgery without pretreatment; however, this did not influence the rate of lymph node metastasis.

Indexed as

Chemoradiotherapy, AdjuvantLymph Node ExcisionRectal NeoplasmsAgedAged, 80 and overCombined Modality TherapyFemaleHumansImage Interpretation, Computer-AssistedLymphatic MetastasisLymph NodesMagnetic Resonance ImagingMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingLocal recurrence rateLymph node analysisPreoperative magnetic resonance imagingResection marginTNM classification

Identifiers

PMID26223668
OpenAlexW1037617383

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.