General_Surgery_News_Article_-_The_Birth_of_Natural_Orifice_Transluminal_Endoscopic_Surgery (5)

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The Birth of Natural Orifice Transluminal
Endoscopic Surgery Through Sometimes
Clandestine Beginnings and Vacillating
Enthusiasm, Researchers Continue Steady Quest
for Improvement
ARTICLE in GENERAL SURGERY & LAPAROSCOPY NEWS · SEPTEMBER 2014
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Daniel Tsin
Mount Sinai Hospital
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ISSUE: SEPTEMBER 2014 | VOLUME: 41:09
In the News
The Birth of Natural Orifice Transluminal
Endoscopic Surgery
Through Sometimes Clandestine Beginnings and Vacillating
Enthusiasm, Researchers Continue Steady Quest for Improvement
by Victoria Stern
Daniel A. Tsin, MD
In 1998, a woman presented to Daniel A. Tsin, MD, FACOG, suffering from infertility and
intense pelvic pain. Dr. Tsin, a gynecologist specializing in minimally invasive techniques,
planned to perform minilaparoscopy to diagnose and treat her problem. During the
procedure, Dr. Tsin found endometriosis and a diseased appendix.
“We opened the vaginal port to prep the base of the appendix for removal, and took out the
appendix through the vagina,” he recalled of his first transvaginal endoscopic appendectomy.
Dr. Tsin’s idea to extract organs through the vagina came several months
earlier during experiments in the animal lab. “I was trying to overcome
the limitations of minilaparoscopy,” said Dr. Tsin, currently the director of
minimally invasive surgery at Mount Sinai Hospital of Queens, Astoria,
N.Y. “The problem is that it’s impossible to remove an appendix, ovary or
gallbladder through 3- to 5-mm ports.”
Dr. Tsin saw a solution in culdoscopy, a technique that provides a view of
the pelvic viscera after a culdoscope is inserted through the vagina.
However, Dr. Tsin took the technique a step further, combining
minilaparoscopy with culdoscopy. He used the vaginal port not only to visualize organs but
also to operate on and extract them.
Dr. Tsin’s first transvaginal appendectomy in a human patient was a success: The woman
had no visible scarring, required almost no pain medications and recovered quickly. Just a
few months later, she became pregnant.
“The team spirit of collaboration was incredible, and we all recognized we were doing things
differently than traditional laparoscopy,” Dr. Tsin recalled.
By 1999, Dr. Tsin’s team performed the first transvaginal endoscopic cholecystectomy in
humans, using a custom-made 46-cm-long laparoscope with a 30-degree angle view (JSLS
2003;7:171-172), and several months later, Dr. Tsin had completed a small series of three
culdolaparoscopic appendectomies and three culdolaparoscopic cholecystectomies.
In November 1999, Dr. Tsin presented the results of the first six cases of culdolaparoscopy at
the 28th annual meeting of the American Association of Gynecologic Laparoscopists, but his
work was largely ignored.
“My team and I were aware of the potential future of flexible technology, but the surgical
community at the time was not ready for the transvaginal endoscopic approach for
cholecystectomy or appendectomy,” Dr. Tsin said. “The surgeons in my hospital were
divided. We had a few defenders, but a majority thought we were delirious.”
http://www.generalsurgerynews.com/PrintArticle.aspx?A_Id=28154&D...
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Anthony Kalloo,
MD
On March 8, 2000, Dr. Tsin’s work came under scrutiny and a special committee decided to
ban the transvaginal procedures. Dr. Tsin was allowed to continue culdolaparoscopy, but only
for gynecologic procedures.
Despite this setback, Dr. Tsin had some supporters in the surgical community, including Paul
A. Wetter, MD, chairman of the Society of Laparoendoscopic Surgeons, whose
encouragement motivated Dr. Tsin to continue his work.
Dr. Tsin subsequently published a range of papers in peer-reviewed journals. For instance, in
2001, Dr. Tsin reported on the feasibility of culdolaparoscopy and completed five
oophorectomies, four myomectomies, three salpingo-ophorectomies and one salpingectomy
using the technique (J Am Assoc Gynecol Laparosc 2001;8:438-441; JSLS 2001;5:69-71).
In 2007, when natural orifice transluminal endoscopic surgery (NOTES) was gaining traction
in the surgical community, Dr. Tsin published a series on the first 100 minilaparoscopy-
assisted natural orifice surgeries, noting only one complication related to antibiotics (JSLS
2007;11:24-29).
“Finally, by 2007, when NOTES began to take off, people started to recognize my
contribution to the field,” Dr. Tsin noted.
NOTES Emerges
In 1997, while Dr. Tsin was experimenting with culdolaparoscopy,
gastroenterologist Anthony N. Kalloo, MD, and six colleagues formed the
Apollo Group, an international think tank of gastroenterologists and
surgeons from different medical and academic centers. The group
included Peter Cotton, MD, Christopher Gostout, MD, Robert Hawes,
MD, Sydney Chung, MD, Pankaj Jay Pasricha, MD, and Sergey
Kantsevoy, MD, PhD. The members of the Apollo Group wanted to take
therapeutic endoscopy to the next level, diagnosing and potentially
treating gastrointestinal disorders through a natural orifice.
“If you think about the way surgery evolved, it started off as very invasive
100 years ago,” Dr. Kalloo said. “With the advent of laparoscopic surgery, we saw that small
incisions were better and patients recovered more quickly. Now, we hoped for endoscopy to
go to the next level with no incisions at all.”
In 1998, Dr. Kalloo was asked to give a talk at Digestive Disease Week (DDW) regarding the
future of endoscopy. “I introduced the concept of breaching the gastric wall to enter the
peritoneal cavity and perform surgery,” said Dr. Kalloo, The Moses and Helen Golden
Paulson Professor of Gastroenterology and director in the Division of Gastroenterology &
Hepatology, Johns Hopkins Hospital, Baltimore. “I believed that the future of endoscopy was
beyond the wall, in the peritoneal and chest cavity.”
After presenting his novel concept, Dr. Kalloo began experimenting with the natural orifice
technique in pigs to determine the feasibility of a transgastric approach to entering the
peritoneal cavity for liver biopsy.
“When we first tried this approach, it was thrilling,” Dr. Kalloo recalled. “To look at organs in
the peritoneal cavity without making an incision across the abdomen was so exciting. We
were fearful, however, about how people would respond and we initially did these surgeries
in secret.”
In the initial feasibility studies, Drs. Kalloo and Kantsevoy successfully entered the peritoneal
cavity of a dozen 50-kg pigs through the mouth and obtained liver biopsies. The pigs
recovered without any leakage or infection, and the team concluded that the procedure was
technically feasible.
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In survival studies, Dr. Kalloo and his colleagues obtained adequate liver biopsy specimens
in five pigs. To help bring the infection rate close to zero, they administered IV antibiotics pre-
and postoperatively, cleaned the oral cavity and irrigated the stomach with antibiotic solution.
All pigs survived, ate heartily the next day and gained weight. Two weeks later, endoscopy
revealed the pigs’ stomachs appeared normal.
“I was amazed at how easily I could see organs and get from one point to another,” Dr.
Kalloo recalled. “This procedure appeared to be a logical next step in the evolution of
minimally invasive techniques.”
Dr. Kalloo initially presented the results at DDW in 2000, and published them four years later
(Gastrointest Endosc 2004;60:114-117).
Beyond the Animal Model
The next major step for NOTES was moving from animal models to humans. In 2003, G.V.
Rao, MS, MAMS, FRCS, chief of surgical gastroenterology and minimally invasive surgery,
and D. Nageshwar Reddy, MD, DM, chief of gastroenterology and therapeutic endoscopy,
Asian Institute of Gastroenterology in Hyderabad, India, performed the first transgastric
appendectomy in a human, removing the appendix through the mouth.
The patient was a young man admitted to the ICU with extensive anterior wall burns. He had
developed acute appendicitis. “We realized that the only way to remove his appendix was
orally through the stomach,” Dr. Reddy said.
The procedure took 1.5 hours under general anesthesia, and the patient did very well,
returning home after 48 hours.
“Of course, it was a nervous time for us as there was a lot of apprehension about performing
the procedure, but this was the only option for the patient,” recalled Dr. Reddy. “We got
praised and criticized for our work.”
On one hand, there were conservative surgeons and physicians who felt this procedure was
too radical, but on the other hand, the duo also received support from the minimally invasive
surgeons and gastroenterologists. After his first presentation at the Digestive Disease Week
in 2003, Dr. Reddy recalled a prolonged ovation and a lot of curiosity.
Drs. Rao and Reddy’s accomplishment was a boon for NOTES. “This advance in humans
generated a lot of excitement and pushed the procedure forward,” Dr. Kalloo said.
Guidelines and Challenges
Despite the potential for NOTES, Dr. Hawes, president of the American Society for
Gastrointestinal Endoscopy (ASGE), and David Rattner, MD, president of the Society of
American Gastrointestinal and Endoscopic Surgeons (SAGES), wanted to ensure that the
technique developed in a safe manner.
“Dr. Rattner and I were very enthusiastic about NOTES, but also aware it could go badly,”
said Dr. Hawes, of the Center for Interventional Endoscopy, Florida Hospital Orlando. “We
wanted to avoid the feeding frenzy that occurred in the early days of laparoscopic
cholecystectomy, which resulted in unnecessary complications. I thought a similar frenzy
might occur with NOTES before the procedure was ready for prime time.”
With the intention of advancing NOTES in a responsible fashion, Drs. Hawes and Rattner
gathered 14 leaders from ASGE and SAGES in July 2005, and formed Natural Orifice
Surgery Consortium for Assessment and Research (NOSCAR). In October of that year, Dr.
Hawes published a white paper on NOTES, identifying the barriers to developing the
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technique and outlining guidelines to move forward (Gastrointest Endosc 2006;63:838-839;
Surg Endosc 2006;20:329-333). The potential challenges of developing NOTES included
gaining safe access to the peritoneal cavity, preventing infection and securing closure of the
gastric incision, as well as providing adequate training and developing enabling
technologies.
Given the success of laparoscopic cholecystectomy, transvaginal cholecystectomy became
the primary procedure investigated to further the science of NOTES.
NOSCAR declared that anyone performing a NOTES procedure would need approval from
an institutional review board. “The purpose was to ensure that people were qualified to use
the technique and were answering the questions that would move NOTES forward,” Dr.
Hawes said. “We formed a research committee, vetted grant requests and received funding,
which allowed researchers to explore the science of NOTES and investigate potential
obstacles as well as how to solve them.”
For instance, there was initial worry about infection in the peritoneal cavity because as soon
as an endoscope comes into contact with the mouth, there are thousands of bacteria;
however, research soon quelled these concerns, showing that this infection risk was
negligible.
Enthusiasm for NOTES started to soar among surgeons and gastroenterologists interested
in pursuing the next cutting-edge surgical technique after laparoscopy. As in the early days of
laparoscopy, there was an influx of interest and funding from corporations, such as Ethicon,
Covidien and Boston Scientific, which helped fuel advances in NOTES research and
development.
Evolution of NOTES: 2007 to Present
After Drs. Rao and Reddy’s initial success in humans and with the guidelines set forth by
NOSCAR, physicians worldwide began cautiously testing the feasibility of NOTES for a
variety of procedures.
In 2007, Jeffrey Ponsky, MD, Department of Surgery, Case Medical Center, Cleveland,
published the first NOTES procedure in humans: a percutaneous endoscopic gastrostomy
rescue. That year, Jacques Marescaux, MD, from University Louis Pasteur, France,
performed the first transvaginal NOTES cholecystectomy (Arch Surg 2007;142:823-826),
and shortly after, a team in Brazil and one in Italy did the same technique in a small series of
patients (J Laparoendosc Adv Surg Tech A 2008;18:345-351; Surg Endosc
2008;22:542-547). General surgeon Lee Swanstrom, MD, conducted the first human
transgastric cholecystectomy (J Surg Oncol 2007;96:678-683). A string of other NOTES firsts
occurred, including a transvaginal appendectomy in 2008 (Surg Endosc 2008;22:1343-1347)
and a NOTES transanal rectal cancer resection in 2009 (Surg Endosc 2010;24:1205-1210).
A 2012 review examined the NOTES landscape from 2007 to 2011, describing 48 studies of
various NOTES procedures in humans (Minim Invasive Surg 2012;2012:189296). Field F.
Willingham, MD, MPH, director of endoscopy in the Division of Digestive Diseases, Emory
University, Atlanta, and his colleagues reported that complication rates varied by procedure
and access site. Transvaginal appendectomy, transgastric and transvaginal gastrectomy, and
transvaginal splenectomy and incisional hernia repair came with very few complications,
whereas transvaginal cholecystectomy (1.5%-25%), transgastric cholecystectomy (18%) and
transgastric appendectomy (33.3%) were associated with more complications. The most
common NOTES procedure was cholecystectomy (75%) and the most common approach
was transvaginal (79%). Additionally, 46% of the procedures were pure NOTES, whereas the
other 54% employed hybrid NOTES techniques.
Dr. Willingham concluded that NOTES has progressed, but barriers remained that limited its
wider acceptance in patients, namely the development of NOTES-specific technologies as
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well as evidence that NOTES offers benefits, beyond cosmesis and reduced pain, over
laparoscopic approaches.
The Future of NOTES
As NOTES evolved, the initial excitement began to wane. Headlines that once asked, “Is
NOTES the Next Laparoscopy?” (GSN, June 2007) now pondered, “Natural Orifice Surgery:
Is the Thrill Gone?” (GSN, March 2012).
Although Drs. Kalloo and Reddy believe that NOTES is ahead of its time, they acknowledge
that it has not followed the striking trajectory of laparoscopy.
“I think what’s happened is that some people think NOTES is taking a long time and hasn’t
done what we expected it to do,” Dr. Kalloo said. “To that, I’d say NOTES is evolving at just
the pace it’s supposed to: slowly and surely. Most importantly, NOTES has not come with
any significant complications or any deaths.”
However, the slow progress of NOTES caused industry’s enthusiasm to fade. “Despite the
reduced pain and cosmetic benefits of NOTES, companies began to see that it wouldn’t
provide the quantum leap that many had hoped and decided to invest in other techniques,
such as single-incision laparoscopy,” said Dr. Hawes. “Without support from industry, it’s
been difficult to continue to make progress.”
Dr. Hawes believes that for NOTES to take off, it will need a home-run application, like
laparoscopic cholecystectomy was for laparoscopic surgery.
“My prediction is that transanal colon resection will be the first true NOTES procedure and
may propel NOTES back into the limelight,” Dr. Hawes said.
Patricia Sylla, MD, FACS, FASCRS, a colorectal surgeon at Massachusetts General Hospital
and assistant professor of surgery at Harvard Medical School, Boston, and Antonio M. de
Lacy, MD, chief of gastrointestinal surgery at the Hospital Clínic of Barcelona, Spain,
pioneered a transanal approach to colorectal surgery. In 2009, Drs. Sylla and de Lacy
performed the first NOTES transanal rectal cancer resection successfully on a 76-year-old
woman with locally advanced rectal cancer using a transanal endoscopic microsurgery
(TEM) platform and laparoscopic assistance (Surg Endosc 2010;24:1205-1210).
Dr. Sylla’s interest in a transanal approach to colorectal surgery began in 2007 at a NOSCAR
conference in Boston, when she attended a presentation by Mark Whiteford, MD, FACS,
FASCRS, on transanal radical sigmoid colectomy in human cadavers using TEM
instrumentation (Surg Endosc 2007;21:1870-1874).
“No one in the audience really responded, but if you understood the TEM platform, you could
see the true potential of this approach,” Dr. Sylla recalled. “I saw this as the future of
colorectal surgery.”
Back at Massachusetts General, Dr. Sylla experimented with the transanal approach to
colorectal surgery on pigs and human cadavers (J Gastrointest Surg 2008;12:1717-1723;
Surg Endosc 2010;24:2022-2030; Surg Endosc 2013;27:74-80). However, performing a pure
NOTES procedure proved difficult, mostly due to limitations in the available instrumentation.
“There are several cases in the literature of pure transanal NOTES colorectal operations, but
this has been in very thin patients,” Dr. Sylla noted. “Once we get more innovative, longer
and flexible instruments, we will be able to perform more pure transanal NOTES procedures,
but a hybrid approach appears to be safest at this time.”
Currently, Drs. Sylla and de Lacy have demonstrated the feasibility and preliminary safety of
laparoscopy-assisted transanal NOTES total mesorectal excision for rectal cancer in 28
patients (Surg Endosc 2013 Mar. [Epub ahead of print]; Surg Endosc 2013 Apr. [Epub ahead
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of print]; Surg Endosc 2013;27:339-346).
Other techniques may have potential to propel NOTES forward. Although not a pure NOTES
procedure, some believe that peroral endoscopic myotomy (POEM), a cross between
laparoscopic surgery and therapeutic endoscopy, may be the first sentinel application to
come out of NOTES, Dr. Willingham said. In 2010, Haruhiro Inoue, MD, a gastroenterologic
surgeon, brought POEM to humans, performing the first series to treat esophageal achalasia
(Endoscopy 2010;42:265-271).
NOTES also may pave the way for hybrid procedures that blend flexible endoscopy with
minimally invasive laparoscopic techniques.
“Many surgeons don’t have extensive experience with flexible endoscopy and
gastroenterologists don’t typically train in laparoscopy,” Dr. Willingham said. “So we are
currently examining whether gastroenterologists and surgeons can work together to develop
a novel solution when the current approach is not good.” For instance, Dr. Willingham and
his colleagues have developed a hybrid laparoscopic and endoscopic approach to removing
mass lesions of the foregut, offering a vast improvement over total gastrectomy (GIE
2012;75:905-912).
Currently, it’s important to show that a pure or hybrid NOTES procedure offers significant
benefits over the standard open or laparoscopic approach to help justify the costs and
training associated with investment in a new procedure, Dr. Sylla said.
Looking to the future, Dr. Kalloo sees surgery becoming increasingly minimally invasive. “I
see a future unfolding in which fewer incisions are the norm,” Dr. Kalloo said. “One hundred
years from now, we’ll look back at open and laparoscopic surgery and say how barbaric that
was, actually creating a big hole across the abdominal wall to help patients.”
Timeline Of Firsts For NOTES
1998 Transvaginal appendectomy, rigid instruments
(J Am Assoc Gynecol Laparosc 2001;8:438-441)
1999
NOTES procedure, swine model
(Gastrointest Endosc 2004;60:114-117)
Transvaginal cholecystectomy, rigid instruments
(JSLS 2003;7:171-172)
2003 Transgastric appendectomy
(Reddy and Rao)
2007
Transvaginal cholecystectomy
(Surg Innov 2007;14:279-283)
Transgastric cholecystectomy
(J Surg Oncol 2007;96:678-683)
Transanal NOTES radical sigmoidectomy, human cadavers
(J Gastroint Surg 2008;12:1717-1723)
POEM, swine model
(Endoscopy 2007;39:761-764)
2008
Transvaginal appendectomy
(Surg Endosc 2008;22:1343-1347)
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NOTES peritoneoscopy
(Surg Endosc 2008;22:16-20)
Transvaginal donor kidney extraction
2009
Transgastric and transvaginal gastrectomy
Transvaginal splenectomy
(Surg Innov 2009;16:218-222)
NOTES transanal rectal cancer resection, first human experience, November
2009
(Surg Endosc 2010;24:1205-1210)
2010
Transvaginal incisional hernia repair
(Hernia 2010;14:89-91)
POEM In Humans
(Endoscopy 2010;42:265-271)
POEM, peroral endoscopic myotomy
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