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

Research output: Contribution to journalArticle

204 Citations (Scopus)

Abstract

Background: Natural-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. Methods: Patients 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. Results: Ten 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. Conclusions: Transgastric 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.

Original languageEnglish (US)
Pages (from-to)16-20
Number of pages5
JournalSurgical Endoscopy and Other Interventional Techniques
Volume22
Issue number1
DOIs
StatePublished - Jan 2008
Externally publishedYes

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Laparoscopy
Clinical Trials
Natural Orifice Endoscopic Surgery
Pancreaticoduodenectomy
Gastric Bypass
Operative Time
Laparotomy
Stomach
Technology
Biopsy
Liver

Keywords

  • Endolumenal Surgery
  • Endoscopic Surgery
  • Natural Orifice Translumenal
  • Transgastric Surgery

ASJC Scopus subject areas

  • Surgery

Cite this

Natural-orifice transgastric endoscopic peritoneoscopy in humans : Initial clinical trial. / Hazey, Jeffrey W.; Narula, Vimal K.; Renton, David B.; Reavis, Kevin M.; Paul, Christopher M.; Hinshaw, Kristen E.; Muscarella, Peter; Ellison, E. Christopher; Melvin, W. Scott.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 22, No. 1, 01.2008, p. 16-20.

Research output: Contribution to journalArticle

Hazey, Jeffrey W. ; Narula, Vimal K. ; Renton, David B. ; Reavis, Kevin M. ; Paul, Christopher M. ; Hinshaw, Kristen E. ; Muscarella, Peter ; Ellison, E. Christopher ; Melvin, W. Scott. / Natural-orifice transgastric endoscopic peritoneoscopy in humans : Initial clinical trial. In: Surgical Endoscopy and Other Interventional Techniques. 2008 ; Vol. 22, No. 1. pp. 16-20.
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AU - Narula, Vimal K.

AU - Renton, David B.

AU - Reavis, Kevin M.

AU - Paul, Christopher M.

AU - Hinshaw, Kristen E.

AU - Muscarella, Peter

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AU - Melvin, W. Scott

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AB - Background: Natural-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. Methods: Patients 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. Results: Ten 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. Conclusions: Transgastric 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.

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