Evidence map›Paper›PMID 34545545›Full record

Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2022

Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection.

Sundeep Singh Saluja, Phani Kumar Nekarakanti, Pramod Kumar Mishra, Anurita Srivastava, Kishore Singh

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02778308 (Randomized Controlled Trial Comparing Adjuvant Chemotherapy Vs. no Chemotherapy for Patients With Carcinoma of Gallbladder Undergoing Curative Resection.), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.9field-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.

NCT02778308 nacompletednot on this map

Randomized Controlled Trial Comparing Adjuvant Chemotherapy Vs. no Chemotherapy for Patients With Carcinoma of Gallbladder Undergoing Curative Resection.

TypeinterventionalSponsorGovind Ballabh Pant Institute of Postgraduate Medical Education and ResearchRan2012 to 2018Enrolled100ConditionsGallbladder CancerArmsGemcitabine + Cisplatin
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  11. Gallbladder cancer.Nature reviews. Disease primers · 2022
    Review
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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

5 authors at 2 institutions in 1 country.

Sundeep Singh SalujaDepartment of Gastrointestinal Surgery, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, India. sundeepsaluja@yahoo.co.in.
Phani Kumar NekarakantiDepartment of Gastrointestinal Surgery, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, India.
Pramod Kumar MishraDepartment of Gastrointestinal Surgery, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, India.
Anurita SrivastavaDepartment of Radiotherapy, Maulana Azad Medical College, New Delhi, India.
Kishore SinghDepartment of Radiotherapy, Maulana Azad Medical College, New Delhi, India.
Govind Ballabh Pant Hospital · INMaulana Azad Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGallbladder carcinoma (GBC) has a dismal prognosis even after curative resection. The objective of the study was to evaluate the effect of adjuvant chemotherapy in patients with GBC undergoing curative resection in a randomized control trial (RCT).

methodsA single-center open-labeled prospective RCT was done from January 2012 to June 2018. R0 curative resected GBC patients were randomized in 1:1 to either surveillance alone (control group) or adjuvant chemotherapy (gemcitabine and cisplatin (GemCis group)) for 6 cycles. The primary outcome was disease-free survival (DFS), and the secondary outcomes were overall survival (OS) and toxicity profile.

resultsOn the evaluation of 362 patients with GBC, 50 patients were enrolled in each control or GemCis group. Per protocol (PP), it comprised 96 patients. The demographic and clinical profile was similar between the two groups except in the lower nodal stage where patients were higher in the control group (p = 0.01). Recurrences were similar between groups (control 44% vs GemCis 56%; p = 0.23). On the intention to treat (ITT), analyses of median DFS (not reached vs. 24 months, p = 0.14) and OS (not reached vs. 31 months, p = 0.10) were similar between groups. On PP, analyses of median DFS (not reached vs. 24 months, p = 0.16) and OS (not reached vs. 31 months, p = 0.09) were similar between groups. The common toxicity profile was hematological followed by gastrointestinal symptoms.

conclusionsAdjuvant GemCis therapy for 6 cycles does not improve DFS or OS than R0 surgery alone patients with GBC.

trial registrationNCT02778308 ( https://www.clinicaltrials.gov ).

Indexed as

CarcinomaGallbladder NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantHumansAdjuvant chemotherapyCisplatinGall bladder carcinomaGemcitabineRCT

Identifiers

PMID34545545
OpenAlexW3199446855

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.