Evidence map›Paper›PMID 21424206›Full record

Trial reportSurgical endoscopy2011

Results of a phase I-II study on intraductal confocal microscopy (IDCM) in patients with common bile duct (CBD) stenosis.

M Giovannini, E Bories, G Monges, C Pesenti, F Caillol, J R Delpero

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
9.0field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Imaging in pancreatic disease.Nature reviews. Gastroenterology & hepatology · 2017
    Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Advanced endoscopic imaging of indeterminate biliary strictures.World journal of gastrointestinal endoscopy · 2015
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

6 authors at 1 institution in 1 country.

M GiovanniniEndoscopic Unit, Paoli-Calmettes Institute, 232 Bd St-Marguerite, 13273, Marseilles cedex 9, France. uemco@marseille.fnclcc.fr
E Bories
G Monges
C Pesenti
F Caillol
J R Delpero
Institut Paoli-Calmettes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConfocal endomicroscopy is an emergent technique and allows real optical biopsies in the gastrointestinal (GI) tract. The aim of this study was to evaluate a new intraductal confocal miniprobe in patients with a normal common bile duct (CBD) or with a suspicion of a malignant stenosis (cholangiocarcinoma).

methodsThirty-seven patients (23 males) underwent endoscopic retrograde cholangiopancreatography (ERCP) for bile duct stone removal (7 cases) or bile duct stenosis (30 cases). Intraductal confocal microscopy (IDCM) was performed during the ERCP using a probe-based confocal laser endomicroscopy (pCLE) technique. IDCM was done with the CholangioFlex probe with Cellvizio (Mauna Kea Technologies, Paris, France). The depth of penetration of theCholangioFlex probe was 40-70 μm and magnification was 400×. Images were reviewed by an experienced pathologist in GI disease and compared to ERCP findings, CBD biopsies performed during ERCP or EUS, and in 15 patients to the resected specimen (Wipple resection).

resultsNo complications related to the CholangioFlex insertion occurred after the ERCP. Good images were obtained in 33 patients. Final histology diagnosis was a normal CBD in 7 cases, 23 malignant stenoses (4 ampullary carcinomas, 13 cholangiocarcinomas, and 6 pancreatic cancer), and 7 inflammatory stenoses (4 chronic pancreatitis, 1 stenosis of hepaticojejunal anastomosis, 1 postcholecystectomy CBD stenosis, and 1 primary sclerosing cholangitis). IDCM of a normal CBD showed a thin black band (<20 μm), normal vessels (thin and regular), and no visible glands. IDCM of malignant strictures revealed irregular vessels with lack of contrast in the CBD wall, large black band (>20 μm), and an aggregate of irregular black cells (black clumps). These aspects were seen in all malignant stenoses and none were seen in benign or normal CBD. The presence of irregular vessels, large black bands, and black clumps seen with confocal laser microscopy enabled prediction of neoplasia with an accuracy rate of 86%, sensitivity of 83%, and specificity of 75%. The respective numbers for standard histopathology were 53, 65, and 53%.

conclusionThis phase I-II study on IDCM showed that IDCM is feasible. This new technique will open a new door for optical biopsy of the CBD.

Indexed as

Microscopy, ConfocalAgedCholangiocarcinomaCholangiopancreatography, Endoscopic RetrogradeCholelithiasisCholestasisCommon Bile Duct NeoplasmsFemaleHumansIntraoperative CareMaleMiddle AgedTreatment Outcome

Identifiers

PMID21424206
OpenAlexW2067038785

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.