VacStent as an Innovative Approach in the Treatment of Anastomotic Insufficiencies and Leakages in the Gastrointestinal Tract-Review and Outlook.

Anastomotic insufficiencies are severe complications of abdominal surgery, often leading to prolonged hospitalization, serious tissue inflammation, and even sepsis, along with the need for recurrent surgery. Current non-surgical treatments such as self-expanding metal stents (SEMSs) and endoscopic vacuum therapy (EVT) have limitations, including stent migration or perforation. This review evaluates the effectiveness of the VacStent GITM (Möller Medical GmbH, Fulda, Germany), a novel medical device combining SEMS and negative-pressure wound therapy in treating gastrointestinal leaks. Data were gathered from four prospective studies and compared with existing treatments. Studies on the VacStent GITM application demonstrate technical success and competitive closure rates in upper gastrointestinal leaks, with minimal complications reported. Comparative analyses with SEMS and EVT reveal promising and most importantly equally good outcomes while maintaining the possibility for sustained enteral nutrition and reducing the risk of stent migration. The VacStent GITM presents a promising alternative to current non-surgical treatments. Ongoing research aims to validate its efficacy in lower gastrointestinal leaks and comprehensively establish its role in leak management. Further investigation is necessary to confirm these findings and optimize treatment protocols. Future usages of the VacStent GITM in colonic anastomotic insufficiencies promise an effective approach and might be able to lower the rates of necessary implementations of a stoma.

Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study.

PURPOSE: Anastomotic leak (AL) represents the most relevant and devastating complication in colorectal surgery. Endoscopic vacuum therapy (EVT) using the VACStent is regarded as a significant improvement in the treatment of upper gastrointestinal wall defects. The innovative concept of the VACStent was transferred to the lower GI tract, gaining initial experience by investigating safety and efficacy in 12 patients undergoing colorectal resections. METHODS: The pilot study, as part of a German registry, began with 2 patients suffering from AL, who were treated with the VACStent after stoma placement. Subsequently, 6 patients with AL were treated with the VACStent omitting a stoma placement, with a focus on fecal passage and wound healing. Finally, the preemptive anastomotic coverage was investigated in 4 patients with high-risk anastomoses to avoid prophylactic stoma placement. RESULTS: In total 26 VACStents were placed without problems. The conditioning and drainage function were maintained, and no clogging problems of the sponge cylinder were observed. No relevant clinical VACStent-associated complications were observed; however, in 2 patients, a dislodgement of a VACStent occurred. The 6 patients with AL but without stoma had a median treatment with 3 VACStents per case with a laytime of 17 days, leading to complete wound healing in all cases. The 4 prophylactic VACStent applications were without complications. CONCLUSION: The clinical application of the VACStent in the lower GI tract shows that successful treatment of anastomotic colonic leaks and avoidance of creation of an anus praeter is possible. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04884334, date of registration 2021-05-04, retrospectively registered.

Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial.

BACKGROUND: Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS: Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS: 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION: DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.

Clinical practice patterns in indirect peroral cholangiopancreatoscopy: outcome of a European survey.

Background and aims Indirect peroral cholangiopancreatoscopy (IPOC) is a relatively new diagnostic and therapeutic tool for biliopancreatic diseases. This international survey aimed to evaluate clinical practice patterns in IPOC among endoscopists in Europe. Methods An online survey was developed comprising 66 questions on the use of IPOC. Questions were grouped into four domains. The survey was sent to 369 endoscopists who perform IPOC. Results 86 respondents (23.3 %) from 21 different countries across Europe completed the survey. The main indications for cholangioscopy were determination of biliary strictures (85 [98.8 %]) and removal of common bile duct or intrahepatic duct stones (79 [91.9 %]), accounting for an estimated use of 40 % (interquartile range [IQR] 25-50) and 40 % (IQR 30-60), respectively, of all cases undergoing cholangioscopy. Pancreatoscopy was mainly used for removal of pancreatic duct stones (68/76 [89.5 %]), accounting for an estimated use of 76.5 % (IQR 50-95) of all cases undergoing pancreatoscopy. Only 13/85 respondents (15.3 %) had an institutional standardized protocol for targeted cholangioscopy-guided biopsy sampling. IPOC with lithotripsy was used as first-line treatment in selected patients with bile duct stones or pancreatic stones by 24/79 (30.4 %) and 53/68 (77.9 %) respondents, respectively. Conclusions This first European survey on the clinical practice of IPOC demonstrated wide variation in experience, indications, and techniques. These results emphasize the need for prospective studies and development of an international consensus guideline to standardize the practice and quality of IPOC.

A new approach to endoscopic treatment of tumors of the esophagogastric junction with individually designed self-expanding metal stents.

The incidence of adenocarcinoma of the esophago-gastric junction is constantly increasing. Curative treatment is no longer possible at the time of diagnosis in more than 50% of patients with esophageal carcinoma, and palliative treatment focusing on eliminating dysphagia is required. Endoscopic therapy with stent implantation is an established method of achieving this. It can be carried out quickly, with a low rate of early complications, and leads to fast symptomatic improvement, assessed using the dysphagia score. The relatively high rate of late complications such as stent migration, hemorrhage, and gastroesophageal mucosal prolapse has led to recent debate on the role of metal stents in palliative therapy. We present here a new type of stent design for transcardial application, which is intended to prevent bleeding due to mechanical mucosal lesions caused by the distal end of the stent extending into the stomach. The further intention of this case report is to force the discussion on individually designed nitinol stents in special anatomic conditions.

Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy.

OBJECTIVE: Percutaneous endoscopic gastrostomy (PEG) using the pull-technique is the standard method for enteral feeding in patients with swallowing disorders. A different introducer technique with endoscopically controlled gastropexy is available avoiding oropharyngeal passage with the internal bumper. The aim of the study was to assess long-term safety of this technique. MATERIAL AND METHODS: Between January 1999 and November 2001, 684 patients received a PEG in our prospective cohort trial. In 92.5% of cases a PEG was applied using the pull-through technique. In 6.7% of the patients (40 males, 6 females, mean age 60.6 yr) primary PEG application using the pull-through technique was not possible and an endoscopical controlled introducer PEG (Cliny PEG 13 CH (=13 F), AP Nenno, Germany) with two gastropexies was placed. Data collection criteria included application success, infectious complications (within 180 days), other complications (within 180 days), and mortality (within 180 days). Procedure, catheter change, and follow-up were standardized. RESULTS: PEG placement was successful in all patients. During initial follow-up we saw a low rate of minor problems. In one case a peristomal peritonitis was seen due to detachment of two gastropexy sutures. During long-term follow-up only one local infection requiring antibiotic treatment occurred on day 14. We observed no treatment related mortality. In most of the patients the primary catheter was changed into a secondary system as scheduled. The average observation period was 131.8 days (range: 15-180 days). CONCLUSION: The Cliny PEG 13 CH can be placed safely in an endoscopically controlled introducer procedure with dual gastropexy. Long-term follow-up of the patients revealed only minor complications. Primary indication is given in patients in whom PEG placement using the pull-through technique is not possible.