Evidence map›Paper›PMID 36330499›Full record

ArticleFrontiers in oncology2022

Feasibility and Efficacy of Adjuvant Chemotherapy With Gemcitabine After Liver Transplantation for Perihilar Cholangiocarcinoma - A Multi-Center, Randomized, Controlled Trial (pro-duct001).

Moritz Schmelzle, Christian Benzing, Lutz Fischer, Uta Herden, Martina Sterneck, Utz Settmacher, Astrid Bauschke, Ulf Neumann, Uwe Pelzer, Tobias Müller and 19 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

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

3 citing papers in PubMed.

  1. Observational
  2. Review
  3. 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

29 authors.

Moritz SchmelzleDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Christian BenzingDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Lutz FischerDepartment of Visceral Transplant Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Uta HerdenDepartment of Visceral Transplant Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Martina SterneckDepartment of Medicine I, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
Utz SettmacherDepartment of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany.
Astrid BauschkeDepartment of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany.
Ulf NeumannDepartment of General, Visceral and Transplant Surgery, University Hospital RWTH Aachen, Aachen, Germany.
Uwe PelzerDepartment of Medicine - Hematology, Oncology and Tumour Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Tobias MüllerDepartment of Medicine - Hepatology and Gastroenterology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Christian StrassburgDepartment of Medicine I, University Hospital Bonn, Bonn, Germany.
Hauke LangDepartment of General, Visceral and Transplant Surgery, University Hospital Mainz, Mainz, Germany.
Thomas BeckerDepartment of General, Visceral, Thoracic, Transplant and Pediatric Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.
Alfred KönigsrainerDepartment of General, Visceral and Transplant, University Hospital Tübingen, Tübingen, Germany.
Silvio NadalinDepartment of General, Visceral and Transplant, University Hospital Tübingen, Tübingen, Germany.
Markus QuanteDepartment of General, Visceral and Transplant, University Hospital Tübingen, Tübingen, Germany.
Andreas PaulDepartment of General, Visceral and Transplant, University Hospital Essen, Essen, Germany.
Helmut FriessDepartment of General, Visceral, Thoracic and Transplant, University Hospital rechts der Isar, München, Germany.
Jürgen KlempnauerDepartment of General, Visceral and Transplant Surgery, Medizinische Hochschule Hannover, Hannover, Germany.
Nicolas RichterDepartment of General, Visceral and Transplant, University Hospital Tübingen, Tübingen, Germany.
Florian VondranDepartment of General, Visceral and Transplant, University Hospital Tübingen, Tübingen, Germany.
Andreas PascherDepartment of General, Visceral and Transplant, University Hospital Münster, Münster, Germany.
Thomas RöschUniversity Hospital Hamburg-Eppendorf, Klinik und Poliklinik für Interdisziplinäre Endoskopie, Hamburg, Germany.
Wenzel SchöningDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Felix KrenzienDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Robert ÖllingerDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Daniel SeehoferDepartment of Visceral, Transplant, Thoracic and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.
Peter NeuhausDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Johann PratschkeDepartment of Surgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Liver transplantation (LT) is considered a therapeutic option for unresectable perihilar cholangiocarcinoma (PHC) within defined criteria. It remains uncertain whether patients can safely receive adjuvant chemotherapy after LT. Methods: We performed a prospective, multi-center, randomized, non-blinded two-arm trial (pro-duct001). Patients after LT for unresectable PHC within defined criteria were randomized to adjuvant gemcitabine (LT-Gem group) and LT alone (LT alone group). The primary objective was to investigate if adjuvant chemotherapy is feasible in ≥ 85% of patients after LT. The primary endpoint was the percentage of patients completing the 24 weeks course of adjuvant chemotherapy. Secondary endpoints included overall survival (OS) and disease-free (DFS), and complication rates. Results: Twelve patients underwent LT for PHC, of which six (50%) were eligible for randomization (LT-Gem: three patients, LT alone: three patients). Two out of three patients discontinued adjuvant chemotherapy after LT due to intolerance. The study was prematurely terminated due to slow enrollment. One patient with PHC had underlying primary sclerosing cholangitis (PSC). Tumor-free margins could be achieved in all patients. In both the LT-Gem and the LT alone group, the cumulative 1-, 3-, and 5-year OS and DFS rates were 100%, 100%, 67%, and 100%, 67% and 67%, respectively. Conclusions: This prospective, multi-center study was prematurely terminated due to slow enrollment and a statement on the defined endpoints cannot be made. Nevertheless, long-term survival data are consistent with available retrospective data and confirm defined criteria for LT. Since more evidence of LT per se in unresectable PHC is urgently needed, a prospective, non-randomized follow-up study (pro-duct002) has since been launched.

Indexed as

adjuvant chemotherapybiliary tract cancergemcitabineklatskin tumorliver transplantationperihilar and intrahepatic cholangiocarcinomaproximal bile duct cancer

Identifiers

PMID36330499
PMCPMC9624225

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