Emerging Technologies

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Article #1

1Surgery for Obesity and Related Diseases 7 (2011) 15–2204/21/23

04/21/23 2Surgery for Obesity and Related Diseases 7 (2011) 15–22

Background

Current gastric restrictive procedures include either a prosthetic device or gastric resection Present the results of a feasibility study using laparoscopic gastric plication for weight loss achieved without stapling or banding

04/21/23 3Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

Two methods were used to achieve laparoscopic gastric volume reduction First group Anterior plication (AP), the anterior gastric wall was folded inward from the fundus to the antrum using 2 rows of running suturesThe greater and lesser curvatures were approximated to create an intraluminal fold of the stomach

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Second group Greater curvature plication (GCP), the short gastric vessels were dividedThe greater curvature was folded inward, with 2 suture lines to reduce the gastric capacity by a large intraluminal gastric fold

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Inclusion criteriaWilling to give consent and comply with the evaluation and treatment schedule21–60 years old (inclusive), had a BMI of ≥35 but ≤50 kg/m2; a BMI of 35–40 kg/m2

with ≥ 1 significant medical conditions related to obesityMeet the NIH criteria for bariatric surgery

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Exclusion criteria Pregnancy or lactation Documented history of drug and/or

alcohol abuse within 2 years Previous procedures performed for the

treatment of obesity Condition that would preclude compliance

with the study (e.g. IBD, congenital or acquired anomalies of GI tract, severe cardiopulmonary disease)

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Exclusion criteria Treatment with ˃50 U/day of insulin Chronic or acute UGIB Cirrhosis, congenital or acquired

intestinal telangiectasia, esophageal or gastric disorders

Hiatal hernia, previous surgery of the foregut

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Exclusion criteria Pancreatitis, an immunocompromised

status or autoimmune connective tissue disease

Use of prescription or over-the-counter weight reduction medications or supplements within 30 days of the screening visit or during study participation

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Surgical procedures AP

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Surgical procedures GCP

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

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Study endpoints Weight loss (weight, BMI,%EWL) Adverse events Endoscopic evaluation Quality-of-life assessment [Quality of

Life-Lite (IWQOL-Lite) and the Multi-purpose Short Form Survey-12 (SF-12)]

Surgery for Obesity and Related Diseases 7 (2011) 15–22

Methods

04/21/23 12Surgery for Obesity and Related Diseases 7 (2011) 15–22

Results

15 patients, 9 underwent AP and 6 underwent GCP (3 males)Mean pre-op BMI was 43.3 kg/m2 (range 36.9–49.0) 9 patients (AP), the 6- and 12-month endoscopic evaluations demonstrated comparable-size plications over time, except for in 1 patient who had a partially disrupted fold

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Results

6 patients (GCP), the 6- and 12-month endoscopic examinations demonstrated a durable intraluminal fold, except for in 1 patient, with a partial disruption at the distal fold owing to a broken sutureFor patients completing 1 year of follow-up, %EWL was 23.3%±24.8% in the AP group (n=5) and 53.4%±22.7% in the GCP group (n=6)

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Results

No bleeding or infectious complications developedThe first patient in the GCP group required reoperation and plication reduction owing to gastric obstruction AP group had no significant change in the SF-12 scores at the 12-month visit compared with the baseline scores

04/21/23 15Surgery for Obesity and Related Diseases 7 (2011) 15–22

Results

GCP group had significant improvement (P˂.001) in the SF-12 scores for the physical component score (questions 1–6) at 12 monthsThe overall (total) IWQOL score had improved significantly (P=.0086) in the GCP group at the 12-month visitNo statistically significant improvement (P= .3753) was observed for the AP group

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Results

Endoscopic images of (A) AP and (B) GCP 12 months postoperatively

04/21/23 17Surgery for Obesity and Related Diseases 7 (2011) 15–22

Results

%EWL over time for gastric plication procedures. Black circles indicate results for AP in present study; white circles, results for GCP in present study; black triangles, results from Ramos et al. [15] for GCP; and black squares, results from Talebpour and Amoli [17] for GCP

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ConclusionOur initial experience has suggested that a reduction in gastric capacity can be achieved by way of plication of the anterior stomach and greater curvatureThe early weight loss results have been encouraging, with better weight loss in patients who underwent GCPThe use of laparoscopic GCP warrants additional investigation as a primary bariatric procedure

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Article #2

Emerging Technologies

Gastrointest Endosc 2010;72:497-504

04/21/23 20Gastrointest Endosc 2010;72:497-504

Background

Medical treatment of obesity often fails, and surgical treatment, although successful, is aggressive To evaluate the short-term safety and efficacy of an endoscopic restrictive implant procedure in the treatment of obesity Prospective, observational studyTertiary-care referral hospital in The Netherlands

04/21/23 21Gastrointest Endosc 2010;72:497-504

Methods

This study involved 13 patients with body mass indexes of between 40 and 50 kg/m2 or between 35 and 40 kg/m2 with obesity related comorbiditiesA new transoral endoscopic restrictive implant procedure in the treatment of obesitySafety of the procedure, percentage of excess weight loss, change in BMI

04/21/23 22Gastrointest Endosc 2010;72:497-504

Methods

04/21/23 23Gastrointest Endosc 2010;72:497-504

Methods

Procedure demonstrated by using animation images. A, The cardia was inspected with the endoscope in retroflex position, and a transmural plication was created by using the stapler. B, An anchor was then pulled through the plication. These steps were repeated until 5 plications with anchors were formed. Next, a multiple-lumen guide was used and served as a guide for the attachment of the restrictor with locking anchor graspers.

04/21/23 24Gastrointest Endosc 2010;72:497-504

Methods

Procedure demonstrated by using animation images. C, The restrictor with a 10-mm food exit orifice was advanced, and the locking anchor graspers were unlocked and withdrawn. D, Once all the anchors had been attached, the restrictor was inspected.

04/21/23 25Gastrointest Endosc 2010;72:497-504

Methods

Endoscopic images of the procedure. A, The cardia was inspected with the gastroscope in retroflex position. B, Next, 5 transmural plications were created and anchors were pulled through the plications. C, Finally, the TERIS-restrictor was in position and inspected.

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Results

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In 1 patient, the procedure was abandoned after a gastric perforation related to stapler malfunctioningIn 2 patients, pneumoperitoneum was detected and desufflated with a percutaneous hollow needle in one patient and treated conservatively in the other At 3 months postprocedure, patients obtained a median EWLof 28% and median BMI decreased from 42.1 to 37.9 kg/m2

Results

04/21/23 28Gastrointest Endosc 2010;72:497-504

Results

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Results

A graphic image shows the median BMI of the patients at baseline, 1 month, and 3 months. BMI, body mass index.

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Results

A box and whisker plot of percentage of excess weight loss, with 25% and 75% interquartile ranges.

04/21/23 31Gastrointest Endosc 2010;72:497-504

Results

04/21/23 32Gastrointest Endosc 2010;72:497-504

ConclusionPreliminary results of this transoral endoscopic restrictive implant system for the treatment of obesity showed successful placement in 12 of 13 patientsProcedural complications occurred in 3 patients Weight loss was comparable to that of laparoscopic gastric band placementFurther long-term studies are under way

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Article #3

Emerging Technologies

Annals of Surgery • Volume 251, Number 2, February 2010

04/21/23 34Annals of Surgery • Volume 251, Number 2, February 2010

Background

The endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients We report on the first European experience with this device

04/21/23 35Annals of Surgery • Volume 251, Number 2, February 2010

Methods

A multicenter, RCT was performed Forty-one patients were included and 30 underwent sleeve implantationEleven patients served as a diet control groupAll patients followed the same low-calorie diet during the study period The purpose of the study was to determine the safety and efficacy of the device

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Methods

Illustration of the EndoBarrier Gastrointestinal Liner. The device is endoscopically placed in the duodenum to form a barrier between chyme and the intestinal wall, creating a duodenal-jejunal bypass effect.

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Methods

The implant device with guide wire, deployment device and encapsulated sleeve.

The device is comprised of an impermeable fluoropolymer sleeve of 60 cm and a nitinol anchor with barbs. The polypropylene drawstring is necessary for removal of the device.

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Methods

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Results

Twenty-six devices were successfully implanted except in 4 patientsFour devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1)The remaining patients all completed the study

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Results

Mean procedure time was 35 minutes (12–102 minutes) for a successful implantation and 17 minutes (5–99 minutes) for explantationDuring the study period the 26 duodenal jejunal bypass sleeve patients (100%) had at least one adverse event, mainly abdominal pain and nausea during the first week after implantation

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Results

04/21/23 42Annals of Surgery • Volume 251, Number 2, February 2010

Results

04/21/23 43Annals of Surgery • Volume 251, Number 2, February 2010

ResultsInitial mean BMI was 48.9 and 47.4 kg/m2 for the device and control patients respectivelyMean EWL after 3 months was 19.0% for device patients versus 6.9% for control patients (P˂0.002) Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m2, respectivelyType 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period

04/21/23 44Annals of Surgery • Volume 251, Number 2, February 2010

Results

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ConclusionThe EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results The device also has a significant positive effect on type 2 diabetes mellitusLong-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity

Emerging Technologies

Other papers of interest

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