Transgastric Peritoneoscopy versus Laparoscopy for the Detection of Peritoneal Metastases

R. P. Voermans; M. Van Berge Henegouwen; S. Conlon; J. Spivey; R. Rowe; B. Sheppard; P. Fockens; D. Faigel

doi:10.1055/s-0028-1087092

Endoscopy, Table of Contents

Transgastric Peritoneoscopy versus Laparoscopy for the Detection of Peritoneal Metastases

RP Voermans ¹^,², M Van Berge Henegouwen ², S Conlon ⁵, J Spivey ⁵, R Rowe ⁵, B Sheppard ⁴, P Fockens ¹, D Faigel ³

¹ Dept. of Gastroenterology and Hepatology
² Dept of Surgery, Academic Medical Center, Amsterdam, The Netherlands
³ Dept. of Gastroenterology and Hepatology, Dept of Surgery, Oregon Health & Science University, Portland, OR, USA
⁴ Dept of Surgery, Oregon Health & Science University, Portland, OR, USA
⁵ Ethicon Endosurgery, Cincinnati, OH, USA

Abstract

Background: If Natural Orifice Transluminal Endoscopic Surgery (NOTES) peritoneoscopy is to become an alternative to diagnostic laparoscopy, it must prove to be at least as accurate as the diagnostic laparoscopy (LAP).

Objective: To create a model of peritoneal metastases for use in the development of transgastric peritoneoscopy (TGP) and to employ this model to compare TGP to LAP.

Methods: This investigator-initiated protocol was performed in a live anesthetized porcine model. 2.5 mm color-coded beads were stapled via LAP to the peritoneum to simulate metastases. Using a non-inferiority design a sample size of 64 beads was determined. Three to seven beads were placed in each of 12 animals. Randomization was performed for number and location of beads. Locations included: abdominal peritoneum (14 beads), diaphragm (11), surface of liver and hepatoduodenal ligament (32), and miscellaneous sites (7): visceral peritoneum, omentum, anterior stomach and pelvis. 3-port LAP was performed by one of two surgeons blinded as to the location and number of beads. TGP was then performed with a 2 channel therapeutic upper endoscope using either standard accessories (forceps, cap) (TGP-s) or with a specially designed toolkit (bendable overtube, articulating retractors and graspers) (TGP-t) in randomized order by one of two endoscopists also blinded to bead placement. A 30 min time limit per examination was used.

Results: A total of 64 beads were placed into 12 pigs. LAP found 61 beads (yield = 95%, 90% CI: 91–100%), TGP-s 40 beads (63%, 90% CI: 52–73%, p = 0.8456 vs. LAP), TGP-t 40 beads (63%, 90% CI: 52–73%, p = 0.7440 vs. LAP). TGP-s and TGP-t were similar in the number, distribution and time to detect beads. TGP was superior for detecting beads on the abdominal and diaphragmatic peritoneum (n = 25) in comparison with beads placed on the liver (n = 32): TGP-s 92% vs. 38% (p < 0.001), TGP-t 100% vs. 34% (p < 0.001).

Conclusions: In this first prospective, blinded, comparative trial TGP was inferior to LAP for the detection of simulated metastases. We successfully created a model for peritoneal metastases. This model will be useful for future device development, which should focus on improved access to the region of the liver and enhanced endoscope optics and performance.