Evidence map›Paper›PMID 17701250›Full record

Trial reportSurgical endoscopy2008

Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial.

Jeffrey W Hazey, Vimal K Narula, David B Renton, Kevin M Reavis, Christopher M Paul, Kristen E Hinshaw, Peter Muscarella, E Christopher Ellison, W Scott Melvin

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00427752 (Diagnostic Transluminal Endoscopic Peritoneoscopy), which is not on this map. Cited by 62 papers.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed
39.1field-weighted citation impact, top 1% 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.

NCT00427752 early_phase1completednot on this map

Diagnostic Transluminal Endoscopic Peritoneoscopy

TypeinterventionalSponsorJeffrey HazeyRan2006 to 2012Enrolled20ConditionsPancreatic CancerArmsTransgastric endoscopic peritoneoscopy.
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 230 citations in OpenAlex.

  1. Trial
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  4. Transvaginal endoscopic surgery for tubal ectopic pregnancy.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Trial
  5. Review
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  7. Natural orifice transluminal endoscopic surgery to the rescue: retrieval of an extraluminally migrated lumen-apposing metal stent.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2024
    Article
  8. Article
  9. Review
  10. Developments in flexible endoscopic surgery: a review.Clinical and experimental gastroenterology · 2015
    Review
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2 more citing papers are in PubMed but not listed here.

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

9 authors at 2 institutions in 1 country.

Jeffrey W HazeyDivision of General Surgery, The Ohio State University Medical Center, Columbus, OH, USA. jeffrey.hazey@osumc.edu
Vimal K Narula
David B Renton
Kevin M Reavis
Christopher M Paul
Kristen E Hinshaw
Peter Muscarella
E Christopher Ellison
W Scott Melvin
The Ohio State University Wexner Medical Center · USThe Ohio State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNatural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy.

methodsPatients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy.

resultsTen patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy.

conclusionsTransgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.

Indexed as

AgedEndoscopy, Digestive SystemFeasibility StudiesFemaleHumansLaparoscopyMaleMiddle AgedMinimally Invasive Surgical ProceduresMouthNeoplasm StagingPancreatic NeoplasmsPilot ProjectsPostoperative PainRisk AssessmentSensitivity and Specificity

Identifiers

PMID17701250
OpenAlexW2015973663

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.