Rationale and Trial Protocol for a Double-Blinded Randomized Controlled Trial to assess the Impact of a Concomitant Crural Repair during Laparoscopic Sleeve Gastrectomy in Patients with a Lax Gastroesophageal Junction without Frank Hiatal Hernia (REPAIR trial protocol).

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The role of crural repair during LSG is still controversial. The preoperative laxity of the gastroesophageal junction (GEJ), graded by the Hill's classification, is more predictive for postoperative GERD and EE after LSG than the presence of a hiatal hernia seen on endoscopy. Thus, the authors hypothesize that a concomitant crural repair in a specific subgroup of patients with a lax GEJ (Hill's III) may reduce the incidence of postoperative GERD and EE. METHODS: A double-blinded, randomized controlled trial of patients with Hill's III GEJ undergoing LSG will be randomized to a concomitant crural repair (experimental) versus LSG alone (control). Primary outcome measures will be presence of EE at 1-year. Secondary outcome measures will include proton pump inhibitor use, postoperative complications, operative time, blood loss, quality of life, GERD and gastrointestinal symptoms. CONCLUSION: Conflicting crural repair results may be explained by differences in preoperative GEJ laxity. Patients with a frank hiatal hernia and patulous GEJ (Hill's IV) have a very high, while patients with an apposed GEJ (Hill's I, Hill's II) have a low incidence of postoperative GERD and EE respectively. Thus, the authors hypothesize that patients with a lax GEJ without frank hiatal hernia (Hill's III), might benefit from a crural repair. This study results can potentially highlight the clinical importance of preoperative endoscopic evaluation of the GEJ in all patients planned for LSG, to determine which subgroup patients may benefit from a crural repair. (Clinicaltrials.gov: NCT05330910, Registered 15-April-2022).

Natural orifice transluminal endoscopic one-anastomosis gastric bypass: a feasibility study using porcine model.

INTRODUCTION: Endoscopic bariatric therapies (EBT) are emerging as effective therapies in the management of overweight patient with or without metabolic syndrome. Unfortunately most procedures only restrict the gastric volume without altering the underlying metabolism which is seen in surgical patients. The aim of this study was to investigate the feasibility and limitations of a natural orifice trans-luminal endoscopic surgery (NOTES) one anastomosis gastric bypass (OAGB). METHODS: NOTES OAGB was performed in three porcine models. The steps of the procedure can be divide as follows: (1) Endoscopic sleeve gastroplasty. (2) Trans-gastric access to peritoneal cavity. (3) Identification of a loop of jejunum. (4) Introduction of the jejunal loop into the stomach. (5) Creation of the gastro-jejunostomy with lumen-apposing metal stent (LAMS). (6) Closure of gastric pylorus with overstitch system. RESULTS: All the animals underwent successful NOTES of OAGB. The mean weight for the animals was 34.3 kg (32-37 kg). The mean procedure time was 250 min (300 min for first animal and 180 min for third animal). The average bypassed bilio-pancreatic limb was 98 cm (range 65-130 cm). CONCLUSIONS: This study has provided proof-of-principle in a preclinical model that a NOTES approach can be used to perform OAGB and, therefore, merits additional evaluation and consideration.

DDW 2016 review: Advances in therapeutic upper gastrointestinal endoscopy.

This is a review of the abstracts presented at Digestive Disease Week 2016, 21-24 May 2016 in San Diego, CA, USA, focusing on novel advances in therapeutic endoscopy of the upper gastrointestinal tract.

Endoscopic Management of Gallbladder Stones: Can We Eliminate Cholecystectomy?

The gold standard for the management of acute cholecystitis is laparoscopic cholecystectomy. In patients that are not fit for surgery, percutaneous cholecystostomy is the standard treatment. However, the procedure is only a temporary measure for controlling gallbladder symptoms and it is frequently associated with morbidities. Recently, endoscopic options for management of acute cholecystitis have been developed. The approach avoids the need for a percutaneous drain and may allow endoscopic treatment of the gallstone. The aim of this article is to provide an overview on the current status of endoscopic management of acute cholecystitis.

Effectiveness of sleeve gastrectomy plus fundoplication versus sleeve gastrectomy alone for treatment of patients with severe obesity: a systematic review and meta-analysis.

BACKGROUND: Laparoscopic sleeve gastrectomy (SG) is a widely performed bariatric surgery, but it is associated with an increased risk of gastroesophageal reflux (GERD) in the long term. The addition of fundoplication to laparoscopic SG may improve lower oesophageal sphincter function and reduce postoperative GERD. OBJECTIVES: This systematic review and meta-analysis aims to compare the efficacy and safety of SG plus fundoplication (SG + F) versus SG alone for the treatment of patients with severe obesity (≥35 kg/m2). SETTING: Meta-analysis. METHODS: Three electronic databases were searched from inception until January 2023. Studies were included if they compared outcomes of SG + F versus SG in patients with severe obesity (≥35 kg/m2). The primary outcome was remission of GERD postoperatively. Secondary outcomes were the percentage of excess weight loss, percentage of total weight loss, postoperative complication rate, operative time, and length of stay. RESULTS: A total of 5 studies with 539 subjects (212 SG + F and 327 SG alone) were included. The mean preoperative body mass index was 42.6 kg/m2. SG + F achieved higher remission of GERD compared with laparoscopic SG (odds ratio [OR] = 13.13; 95% CI, 3.54-48.73; I2 = 0%). However, the percentage of total weight loss was lower in the SG + F group (mean difference [MD] = -2.75, 95% CI, -4.28 to -1.23; I2 = 0%), whereas there was no difference in the percentage of excess weight loss (MD = -0.64; 95% CI, -20.62-19.34; I2 = 83%). There were higher postoperative complications in SG + F (OR = 2.56; 95% CI, 1.12-5.87; I2 = 0%) as well. There was no difference in operative time or length of stay between the 2 groups. CONCLUSION: SG + F achieved better GERD remission but is associated with lesser weight loss and increased postoperative complications compared with SG alone. Further studies are required to ascertain the overall clinical benefit of SG + F for patients with severe obesity.

Endoscopic internal drainage with double pigtail stents for upper gastrointestinal anastomotic leaks: suitable for all cases?

BACKGROUND/AIMS: Surgeons and endoscopists have started to use endoscopically inserted double pigtail stents (DPTs) in the management of upper gastrointestinal (UGI) leaks, including UGI anastomotic leaks. We investigated our own experiences in this patient population. METHODS: From March 2017 to June 2020, 12 patients had endoscopic internal drainage of a radiologically proven anastomotic leak after UGI surgery in two tertiary UGI centers. The primary outcome measure was the time to removal of the DPTs after anastomotic healing. The secondary outcome measure was early oral feeding after DPT insertion. RESULTS: Eight of the 12 patients (67%) required only one DPT, whereas four (33%) required two DPTs. The median duration of drainage was 42 days. Two patients required surgery due to inadequate control of sepsis. Of the remaining 10 patients, nine did not require a change in DPT before anastomotic healing. Nine patients were allowed oral fluids within the 1st week and a soft diet in the 2nd week. One patient was allowed clear oral feeds on the 8th day after DPT insertion. CONCLUSION: Endoscopic internal drainage is becoming an established minimally invasive technique for controlling anastomotic leak after UGI surgery. It allows for early oral nutritional feeding and minimizes discomfort from conventional external drainage.

Natural Orifice Transluminal Endoscopic One-Anastomosis Gastric Bypass: a Feasibility Study Using Human Cadavers.

BACKGROUND: Endoscopic bariatric therapies (EBT) has emerged as an effective treatment in the management of the patient with obesity. Unfortunately, most procedures involve only the restriction of gastric volume without altering the underlying metabolism. The objective of this study was to investigate the practicability and limitations of the metabolic altering procedures: "One anastomosis gastric bypass (OAGB)" with "natural orifice transluminal endoscopic surgery (NOTES)" on human cadavers. METHODS: We performed OAGB with NOTES approach in 3 human cadavers. The steps of the procedure can be divided as follows: step 1, endoscopic sleeve gastroplasty (ESG); step 2, trans-gastric access to peritoneal cavity; step 3, identification of suitable loop of jejunum; step 4, introduction of the jejunal loop into the stomach; step 5, creation of the gastro-jejunostomy with lumen-apposing metal stent (LAMS); step 6, gastric pylorus occlusion with overstitch. RESULTS: We performed OAGB with NOTES in 3 human cadavers with bypassed bilio-pancreatic limb of 55, 75, and 105 cm from the pylorus. The average weight for the cadavers was 64.9 kg (61.2-71.7 kg). The mean procedure time was 157 min. The optimal bypassed length for the procedure was 105 cm. CONCLUSIONS: This study has provided proof-of-principle in a pre-clinical cadaveric model that NOTES approach can be used to perform OAGB and, therefore, merits additional evaluation and consideration in surviving porcine model.

The Hill's Classification Is Useful to Predict the Development of Postoperative Gastroesophageal Reflux Disease and Erosive Esophagitis After Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is one of the commonest bariatric procedures. However, it is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). This study aims to assess the impact of various preoperative clinical and endoscopic characteristics on the development of postoperative GERD and EE. METHODS: This study is a single-institution retrospective cohort study involving all patients who underwent LSG. A univariate and multivariate analysis was performed to identify preoperative parameters that were significantly associated with the development of postoperative GERD and EE, at up to 1-year follow-up. RESULTS: At up to 1-year follow-up, out of 127 patients, only preoperative endoscopic presence of a hiatal hernia noted on axial length (p=0.024) and the Hill's classification of the gastroesophageal junction (p<0.001) were significantly associated with the development of postoperative GERD. Similarly, at 1-year follow-up endoscopy, the presence of a hiatal hernia (p=0.041) and the Hill's classification (p=0.001) were associated with postoperative EE. On the multivariate analysis, compared to patients with a Hill's I flap valve, Hill's II patients were more likely to develop postoperative GERD (OR 7.13, 95% CI: 1.69-29.98, p=0.007), and Hill's III patients were more likely to develop postoperative GERD (OR 20.84, 95% CI: 3.98-109.13, p<0.001) and EE (OR 34.49, 95% CI: 1.08-1105.36, p=0.045). All patients with Hill's IV developed postoperative GERD and EE in this study. CONCLUSION: Postoperative GERD and EE remain an important limitation following LSG. Proper preoperative assessment using the Hill's classification can help to accurately predict patients at risk of postoperative GERD and EE.

Laparoscopic resectional oesophago-gastroplasty: a novel technique for minimally invasive treatment of large high gastric lesser curve GIST involving gastroesophageal junction.

A paramount factor in selecting the operative approach for gastric gastrointestinal stromal tumours (GIST) is tumour location. Tumours located high along the lesser curve of the stomach pose a challenge in laparoscopic resection. A 56-year-old lady presented with per rectal bleeding and loss of weight. Endoscopic and radiological investigations revealed a large gastric GIST located over the lesser curve with proximal margin <1 cm from the gastroesophageal junction (GEJ). We present the steps of a novel technique for laparoscopic resectional oesophago-gastroplasty to resect large high gastric lesser curve GIST involving the GEJ.

Mesenchymal stem cells promote healing of nonsteroidal anti-inflammatory drug-related peptic ulcer through paracrine actions in pigs.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most important causes of peptic ulcer disease in high-income countries. Proton pump inhibitors are the current standard treatment; however, safety and long-term adverse effects of using these drugs are attracting more and more concerns in recent years. Using a porcine model of NSAID-related gastric ulcer, we herein show that adipose-derived mesenchymal stem cells (ADMSCs) delivered by endoscopic submucosal injection promoted ulcer healing with less inflammatory infiltration and enhanced reepithelization and neovascularization at day 7 and day 21 when compared with the controls (saline injection). However, only few engrafted ADMSCs showed myofibroblast and epithelial cell phenotype in vivo, suggesting the ulcer healing process might be much less dependent on the stem cell transdifferentiation. Further experiment with submucosal injection of MSC-derived secretome revealed a therapeutic efficacy comparable to that of stem cell transplantation. Profiling analysis showed up-regulation of genes associated with inflammation, granulation formation, and extracellular matrix remodeling at day 7 after injection of MSC-derived secretome. In addition, the extracellular signal-regulated kinase/mitogen-activated protein kinase and the phosphoinositide-3-kinase/protein kinase B pathways were activated after injection of ADMSCs or MSC-derived secretome. Both signaling pathways were involved in mediating the major events critical to gastric ulcer healing, including cell survival, migration, and angiogenesis. Our data suggest that endoscopic submucosal injection of ADMSCs serves as a promising approach to promote healing of NSAID-related peptic ulcer, and the paracrine effectors released from stem cells play a crucial role in this process.

Application of robotics in gastrointestinal endoscopy: A review.

Multiple robotic flexible endoscope platforms have been developed based on cross specialty collaboration between engineers and medical doctors. However, significant number of these platforms have been developed for the natural orifice transluminal endoscopic surgery paradigm. Increasing amount of evidence suggest the focus of development should be placed on advanced endolumenal procedures such as endoscopic submucosal dissection instead. A thorough literature analysis was performed to assess the current status of robotic flexible endoscopic platforms designed for advanced endolumenal procedures. Current efforts are mainly focused on robotic locomotion and robotic instrument control. In the future, advances in actuation and servoing technology, optical analysis, augmented reality and wireless power transmission technology will no doubt further advance the field of robotic endoscopy. Globally, health systems have become increasingly budget conscious; widespread acceptance of robotic endoscopy will depend on careful design to ensure its delivery of a cost effective service.

An innovative ex-vivo porcine upper gastrointestinal model for submucosal tunnelling endoscopic resection (STER).

Background and study aims: Submucosal tunnelling endoscopic resection (STER) is a novel endoscopic technique to remove submucosal tumour (SMT). We propose a novel, low cost simulator for training of techniques for STER. Patients and methods: The model consisted of an ex-planted porcine oesophagus, stomach and duodenum with marbles embedded surgically in the submucosal plane. Two expert endoscopists with experience in submucosal tunnelling and 5 board-certified endoscopists with no experience in submucosal tunnelling were recruited. Participants were asked to perform a diagnostic endoscopy and 2 STER procedures, 1 in the oesophagus and 1 in the stomach. They also answered a structured questionnaire. Factors including operative time, mucosal and muscular injury rate, injection volume and accuracy of endoscopic closure were assessed. Results: The median time for localization of all SMTs was 40.1 seconds for experts and 38.5 seconds for novices (P = 1.000). For esophageal STER, the length of mucosal incisions and tunnelling distances were comparable between the 2 groups. The median volume injected by the novice group was significantly lower than the experts (15 mL vs 42.5 mL (P = 0.05). The median tunnelling time per length was 25.9 seconds/mm for the experts and 40.8 seconds/mm for the novice group (P = 0.38). There was a higher rate of mucosal injury and muscular perforation in the novice group (8 vs 0; P = 0.05). For gastric STER, the length of mucosal incisions and tunnel distances were comparable between the 2 groups. The median tunnelling time per length for the experts was 23.3 seconds/mm and 34.6 seconds/mm for the novice group (P = 0.38). One mucosal injury was incurred by a novice. The rate of dissection in the stomach and the oesophagus was not statistically different (P = 0.620). All participants voted that the model provides a realistic simulation and recommended it for training. Conclusions: STER is an advanced endoscopic technique where its indication is currently explored. Experienced and novice STER endoscopists have expressed the usefulness of this model as a training tool. This low-cost model can be used for future research in STER.

A technical review of flexible endoscopic multitasking platforms.

BACKGROUND: Further development of advanced therapeutic endoscopic techniques and natural orifice translumenal endoscopic surgery (NOTES) requires a powerful flexible endoscopic multitasking platform. METHODS: Medline search was performed to identify literature relating to flexible endoscopic multitasking platform from year 2004-2011 using keywords: Flexible endoscopic multitasking platform, NOTES, Instrumentation, Endoscopic robotic surgery, and specific names of various endoscopic multitasking platforms. Key articles from articles references were reviewed. RESULTS: Flexible multitasking platforms can be classified as either mechanical or robotic. Purely mechanical systems include the dual channel endoscope (DCE) (Olympus), R-Scope (Olympus), the EndoSamurai (Olympus), the ANUBIScope (Karl-Storz), Incisionless Operating Platform (IOP) (USGI), and DDES system (Boston Scientific). Robotic systems include the MASTER system (Nanyang University, Singapore) and the Viacath (Hansen Medical). The DCE, the R-Scope, the EndoSamurai and the ANUBIScope have integrated visual function and instrument manipulation function. The IOP and DDES systems rely on the conventional flexible endoscope for visualization, and instrument manipulation is integrated through the use of a flexible, often lockable, multichannel access device. The advantage of the access device concept is that it allows optics and instrument dissociation. Due to the anatomical constrains of the pharynx, systems are designed to have a diameter of less than 20 mm. All systems are controlled by traction cable system actuated either by hand or by robotic machinery. In a flexible system, this method of actuation inevitably leads to significant hysteresis. This problem will be accentuated with a long endoscope such as that required in performing colonic procedures. Systems often require multiple operators. To date, the DCE, the R-Scope, the IOP, and the Viacath system have data published relating to their application in human. CONCLUSION: Alternative forms of instrument actuation, camera control and master console ergonomics should be explored to improve instrument precision, sphere of action, size and minimize assistance required.

Choledochal malformations: the Scottish experience.

INTRODUCTION: Excisional surgery for choledochal malformations in Scotland is currently performed in three specialist pediatric surgical centers using open or laparoscopic-assisted techniques. We reviewed the outcome of children who had excisional surgery in Scotland between 1992 and 2010. MATERIALS AND METHODS: Case notes for all patients undergoing excisional surgery in any of the three specialist pediatric surgical centers in Scotland between 1992 and 2010 were retrospectively reviewed. RESULTS: A total of 25 patients were identified, with a female preponderance of 4:1. Of these, three patients (12%) were diagnosed by antenatal ultrasound scan. The commonest presenting symptoms were anorexia (56%), abdominal pain (52%), and jaundice (52%). Only 20% had the classical triad of abdominal pain, jaundice, and a palpable mass. Using the King's College Hospital classification, 14 patients had type 1 malformations, 8 had type 4 malformations, and 3 had type 2 malformations. Median age at operation was 2 years (range 35 days to 13.5 years). Two centers performed open excision while the third center used primarily a laparoscopic-assisted technique. Median follow-up was 2.1 years (range 30 days to 11.9 years). Three patients (12%) required repeat laparotomy. The wound infection rate was 8% (n=2). The recurrent cholangitis rate was 8% (n=2). There was one late death due to adhesive small bowel obstruction, 4 years after surgery. To date, no patient has developed biliary tree stones or liver failure. CONCLUSIONS: Choledochal malformation excisional surgery, either open or laparoscopic assisted, can be safely performed in appropriately equipped, pediatric surgical centers in Scotland by experienced pediatric surgeons.