Evidence map›Paper›PMID 36253625›Full record

SynthesisSurgical endoscopy2023

Trial sequential meta-analysis of laparoscopic versus open pancreaticoduodenectomy: is it the time to stop the randomization?

Claudio Ricci, Alberto Stocco, Carlo Ingaldi, Laura Alberici, Francesco Serbassi, Emilio De Raffele, Riccardo Casadei

Open access · hybridFull text readMeta-Analysis
In one paragraph

Synthesis in Surgical endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Network Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials Comparing Robotic, Laparoscopic, and Open Pancreatoduodenectomy.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2024
    Article
  5. 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

7 authors at 3 institutions in 1 country.

Claudio RicciDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy. claudio.ricci6@unibo.it.
Alberto StoccoDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Carlo IngaldiDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Laura AlbericiDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Francesco SerbassiDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Emilio De RaffeleDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Riccardo CasadeiDivision of Pancreatic Surgery, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, via Albertoni 15-Italia, Bologna, Italy.
Azienda USL di Bologna · ITPoliclinico S.Orsola-Malpighi · ITUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe advantages of LPD compared with OPD remain debatable. The study aimed to compare the laparoscopic (LPD) versus open (OPD) for pancreaticoduodenectomy.

methodsA meta-analysis of randomized studies (RCTs) comparing LPD and OPD was made. The results were reported as relative risk (RRs) or mean differences (MDs). The trial sequential analysis was used to test the type I and type II errors defining the required information size (RIS). The primary outcome was mortality, major morbidity, and postoperative pancreatic fistula (POPF). R1 resection, post-pancreatectomy hemorrhage, delayed gastric emptying, biliary fistula, reoperation, readmission, operative time (OT), lymph nodes harvested, and length of stay (LOS) were also studied.

resultsFour RCTs, counting 818 patients, were found. The RRs for mortality, major morbidity, and POPF were 1.16, 1.04, and 0.86, without significant differences. The RISs were 35,672, 16,548, and 8206. To confirm this equivalence, at least 34,854, 15,730, and 7338 should be randomized. OT was significantly longer in LPD than OPD, with an MD of 63.22. The LOS was significantly shorter in LPD than in OPD, with - 1.76 days. The RISs were 1297 and 1273, excluding a false-positive result. No significant differences were observed for the remaining endpoints, and RISs suggested that more than 3000 patients should be randomized to confirm the equivalence.

conclusionThe equivalence of LPD and OPD for mortality, major morbidity, and POPF is affected by type II error. The RISs to demonstrate a superiority of one of the two techniques seem unrealistic to obtain.

Indexed as

LaparoscopyPancreatic NeoplasmsHumansLength of StayPancreatectomyPancreatic FistulaPancreaticoduodenectomyPostoperative ComplicationsRandom AllocationRandomized Controlled Trials as TopicRetrospective Studies

Identifiers

PMID36253625
PMCPMC10017649
OpenAlexW4306412171

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read58
identifiers read2
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.