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2.
J Assoc Physicians India ; 72(1): 14-16, 2024 Jan.
Article En | MEDLINE | ID: mdl-38736068

BACKGROUND: In recent years, there has been an alarming increase in cases of gastric outlet obstruction (GOO) at our center due to drug abuse. So, we conducted this study to know the incidence of nonsteroidal anti-inflammatory drugs (NSAIDs) and synthetic opioid abuse in cases of GOO. METHODS: This was an observational study involving consecutive cases of GOO diagnosed from September 2017 to February 2019. A detailed history, including drug addiction history and clinical examination, was done. Investigations included routine biochemical and hematological tests, upper gastrointestinal endoscopy (UGIE), ultrasonography, rapid urease test (RUT), and histopathology of the diseased area. RESULTS: Among the 102 cases diagnosed with GOO, 62 (60.78%) cases had a history of drug addiction. The drug addiction history was as follows: NSAIDs and opioids in 56, opioids alone in four, and NSAIDs alone in two cases. The most common site of stricture was the second part of the duodenum. The features on histopathology were ulcerations of the mucosa infiltrated by eosinophils, plasma cells, and lymphocytes. CONCLUSION: There is an alarming increase in the incidence of GOO due to NSAIDs and opioid abuse at our center. Efforts should be made to control the indiscriminate use of these over-the-counter drugs to prevent dreaded complications.


Analgesics, Opioid , Anti-Inflammatory Agents, Non-Steroidal , Gastric Outlet Obstruction , Humans , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , India/epidemiology , Incidence , Male , Female , Adult , Analgesics, Opioid/adverse effects , Middle Aged , Gastric Outlet Obstruction/chemically induced , Gastric Outlet Obstruction/epidemiology , Gastric Outlet Obstruction/etiology , Opioid-Related Disorders/epidemiology , Young Adult , Aged
3.
Medicina (Kaunas) ; 60(4)2024 Apr 16.
Article En | MEDLINE | ID: mdl-38674284

Gastrojejunostomy is the principal method of palliation for unresectable malignant gastric outlet obstructions (GOO). Gastrojejunostomy was traditionally performed as a surgical procedure with an open approach butrecently, notable progress in the development of minimally invasive procedures such as laparoscopic gastrojejunostomies have emerged. Additionally, advancements in endoscopic techniques, including endoscopic stenting (ES) and endoscopic ultrasound-guided gastroenterostomy (EUS-GE), are becoming more prominent. ES involves the placement of self-expandable metal stents (SEMS) to restore luminal patency. ES is commonly the first choice for patients deemed unfit for surgery or at high surgical risk. However, although ES leads to rapid improvement of symptoms, it carries limitations like higher stent dysfunction rates and the need for frequent re-interventions. Recently, EUS-GE has emerged as a potential alternative, combining the minimally invasive nature of the endoscopic approach with the long-lasting effects of a gastrojejunostomy. Having reviewed the advantages and disadvantages of these different techniques, this article aims to provide a comprehensive review regarding the management of unresectable malignant GOO.


Gastric Outlet Obstruction , Gastric Outlet Obstruction/surgery , Gastric Outlet Obstruction/etiology , Humans , Palliative Care/methods , Gastric Bypass/methods , Stents , Endosonography/methods , Stomach Neoplasms/complications , Stomach Neoplasms/surgery
4.
Surg Endosc ; 38(6): 3231-3240, 2024 Jun.
Article En | MEDLINE | ID: mdl-38649494

BACKGROUND: Malignant Gastric Outlet Obstruction (mGOO) has been standardly treated by surgical Gastrojejunostomy (S-GJ) or Endoscopic Stenting (ES). Recently, EUS-Gastrojejunostomy (EUS-GJ) has emerged as an alternative, despite its worldwide diffusion is heterogeneous. The aim of this survey was to assess clinical decision-making around mGOO and to explore current opinions regarding EUS-GJ. METHODS: An online survey, spread through social networks and EPC newsletter, was created exploring opinions regarding indications, contraindications, benefits/risks, availability of mGOO treatments; 2 case vignettes explored clinical decision-making in different scenarios. RESULTS: Overall, 290 pancreatologists from 44 countries responded, of whom 35% surgeons and 65% gastroenterologists. The most common treatment for mGOO was ES (86%), followed by laparoscopic GJ (76%). EUS-GJ was accessible to 59% of respondents, with 10% proficient in this technique. Gold-standard treatment for mGOO varied by specialty; 45% of gastroenterologists preferred ES, 20% EUS-GJ, and 10% surgical GJ, while among surgeons, these were 24%, 8%, and 25%, respectively. A higher annual volume of mGOO treated correlated with increased EUS-GJ adoption and reduced surgical advice. For 51%, EUS-GJ will become the primary treatment for mGOO, notably higher among gastroenterologists and high-volume centers. For 14%, EUS-GJ spread will be limited in the future, or used only when ES fails (19%). Life expectancy, disease stage and patient's frailty are the main decision driver in therapeutic choice, whereas future surgical resectability does not contraindicate any treatment for 75%. EUS-GJ's main advantages were its minimally invasive nature and clinical efficacy, offset by its steep learning curve. CONCLUSIONS: This survey revealed significant differences in the management of mGOO, depending on specialties, local expertise and treatment volume, suggesting the lack of standardized algorithms. Life expectancy and patients' frailty are the main decision drivers. Regarding EUS-GJ, its availability remains suboptimal, with learning curve as the main perceived barrier.


Gastric Bypass , Gastric Outlet Obstruction , Pancreatic Neoplasms , Practice Patterns, Physicians' , Gastric Outlet Obstruction/surgery , Gastric Outlet Obstruction/etiology , Humans , Pancreatic Neoplasms/complications , Pancreatic Neoplasms/surgery , Gastric Bypass/methods , Practice Patterns, Physicians'/statistics & numerical data , Endosonography/methods , Male , Clinical Decision-Making , Female , Stents , Surveys and Questionnaires , Europe , Middle Aged
5.
Surg Endosc ; 38(4): 2078-2085, 2024 Apr.
Article En | MEDLINE | ID: mdl-38438674

BACKGROUND: Symptomatic malignant gastric outlet obstruction (GOO) significantly reduce patients' quality of life. Endoscopic treatment involves enteral stenting or endoscopic ultrasonography to perform gastroenterostomy (EUS-GE). Aim was to compare enteral stenting with EUS-GE for endoscopic treatment of malignant GOO. METHODS: We retrospectively compared enteral stenting with EUS-GE for the treatment of malignant GOO. Patients treated at our institution were identified and a propensity score matching analysis was performed. Treatment failure was the primary outcome, while the secondary endpoints were time until treatment failure, technical and clinical success rates, and adverse event rates. RESULTS: Eighty-eight patients were included in the final analysis. Of whom, 44 were included in each of the two treatment groups. Treatment failure occurred significantly more frequently in the enteral stenting group (13/44) compared with the EUS-GE group (4/44; hazard ratio: 4,9; 95% CI 1.6-15.1). A Kaplan-Meier analysis revealed a median time until treatment failure of 22.0 weeks (95% CI 4.6-39.4) in the enteral stenting group compared with 76.0 weeks (95% CI 55.9-96.1) in the EUS-GE group (P = .002). No difference in technical success and clinical success was detected. Technical success was achieved in 43/44 patients (97.7%) in the enteral stenting group compared with 41/44 patients (93.2%) in the EUS-GE group, while clinical success was achieved in 32/44 (72.7%) and 35/44 (79.5%) patients, respectively. Nine adverse events were observed (9/44, 10.2%). There were no differences in 30-day adverse event rate and 30-day mortality rate. CONCLUSION: EUS-GE was superior to enteral stenting in the treatment of malignant GOO in terms of treatment failure and time until treatment failure in a propensity score-matched cohort.


Endosonography , Gastric Outlet Obstruction , Humans , Retrospective Studies , Propensity Score , Quality of Life , Stents , Gastroenterostomy , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Ultrasonography, Interventional
7.
Am J Case Rep ; 25: e942938, 2024 Feb 03.
Article En | MEDLINE | ID: mdl-38308432

BACKGROUND Obesity is a global epidemic often managed through surgical interventions, such as intragastric balloons. Despite the minimally invasive appeal of intragastric balloons, severe complications, such as gastric outlet obstruction, can occur with their use. The most recent guidelines recommend metabolic and bariatric surgery for specific body mass index categories but rarely discuss the potential complications and required postoperative monitoring. Guidelines encourage metabolic and bariatric surgery for patients with a body mass index of 30-34.9 kg/m² and presence of metabolic disease, or body mass index ≥35 kg/m², regardless of co-morbidities. CASE REPORT We report a case of a 35-year-old woman with severe nausea, vomiting, electrolyte imbalance, and chest pain, leading to ICU admission just 2 weeks after intragastric balloon placement in Mexico. Testing and diagnostics were concerning for metabolic imbalance and heart rhythm changes. Imaging and endoscopic investigations confirmed gastric outlet obstruction, necessitating emergent endoscopic balloon deflation and removal. Following the procedure, her symptoms resolved, and she was discharged with appropriate medication and scheduled follow-up. CONCLUSIONS Given the increasing prevalence of obesity and a corresponding surge in surgical interventions, this case serves as a cautionary tale. Selection of a type of metabolic and bariatric surgery should be patient specific, with the patient involved in the decision making. Rigorous preoperative assessments and sustained postoperative monitoring are imperative. This study aims to guide future research toward enhanced patient selection and prevention of severe complications, thus influencing practice and policy in obesity management.


Bariatric Surgery , Gastric Balloon , Gastric Outlet Obstruction , Obesity Management , Obesity, Morbid , Female , Humans , Adult , Obesity/complications , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Obesity, Morbid/complications , Obesity, Morbid/surgery
8.
Med Sci (Basel) ; 12(1)2024 Feb 01.
Article En | MEDLINE | ID: mdl-38390859

Gastric outlet obstruction (GOO) poses a common and challenging clinical scenario, characterized by mechanical blockage in the pylorus, distal stomach, or duodenum, resulting in symptoms such as nausea, vomiting, abdominal pain, and early satiety. Its diverse etiology encompasses both benign and malignant disorders. The spectrum of current treatment modalities extends from conservative approaches to more invasive interventions, incorporating procedures like surgical gastroenterostomy (SGE), self-expandable metallic stents (SEMSs) placement, and the advanced technique of endoscopic ultrasound-guided gastroenterostomy (EUS-GE). While surgery is favored for longer life expectancy, stents are preferred in malignant gastric outlet stenosis. The novel EUS-GE technique, employing a lumen-apposing self-expandable metal stent (LAMS), combines the immediate efficacy of stents with the enduring benefits of gastroenterostomy. Despite its promising outcomes, EUS-GE is a technically demanding procedure requiring specialized expertise and facilities.


Gastric Outlet Obstruction , Gastroenterostomy , Humans , Gastroenterostomy/adverse effects , Gastroenterostomy/methods , Endosonography/adverse effects , Endosonography/methods , Gastric Outlet Obstruction/diagnostic imaging , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Pylorus/surgery , Stents/adverse effects , Constriction, Pathologic/complications , Constriction, Pathologic/surgery
10.
Lancet Gastroenterol Hepatol ; 9(2): 124-132, 2024 02.
Article En | MEDLINE | ID: mdl-38061378

BACKGROUND: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting. METHODS: The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed. FINDINGS: Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08-0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related. INTERPRETATION: In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available. FUNDING: Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.


Gastric Outlet Obstruction , Stomach Neoplasms , Male , Humans , Female , Adolescent , Adult , Aged , Endosonography/methods , Treatment Outcome , Gastroenterostomy/adverse effects , Gastroenterostomy/methods , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Stomach Neoplasms/surgery , Stents
11.
Dig Endosc ; 36(4): 428-436, 2024 Apr.
Article En | MEDLINE | ID: mdl-37522554

OBJECTIVES: The aim of the current study was to compare the efficacy of partially covered duodenal stent (PCDS) vs. uncovered duodenal stent (UCDS) in patients suffering from unresectable primary malignant gastric outlet obstruction (GOO). METHODS: This was a prospective international randomized controlled study conducted in 10 high-volume institutions. Consecutive patients suffering from malignant GOO were recruited. The primary outcome measurement was the reintervention rate. Secondary outcomes included technical and clinical success, 30-day adverse events, 30-day mortality, causes of stent dysfunction, and the duration of stent patency. RESULTS: Between March 2017 and October 2020, 115 patients (59 PCDS, 56 UCDS) were recruited. The 1-year reintervention was not significantly different (PCDS vs. UDCS = 12/59, 20.3% vs. 14/56, 25%, P = 0.84). There was a trend to fewer patients with tumor ingrowth in the PCDS group (6/59 [10.2%]) vs. 13/56 [23.2%], P = 0.07). There were no significant differences in the technical success (100% vs. 100%, P = 1), clinical success (91.5% vs. 98.2%, P = 0.21), procedural time (21.5 [interquartile range [IQR] 17-30] vs. 20.0 [IQR 15-34.75], P = 0.62), hospital stay (4 [IQR 3-12] vs. 5 [IQR 3-8] days, P = 0.81), 30-day adverse events (18.6% vs. 14.3%, P = 0.62), or 30-day mortality (6.8% vs. 5.2%, P = 1.00). CONCLUSION: The use of PCDS was associated with a lower risk of tumor ingrowth but did not improve on reintervention rates or stent patency. Both kinds of stents could be used in this group of patients.


Gastric Outlet Obstruction , Neoplasms , Humans , Prospective Studies , Treatment Outcome , Stents/adverse effects , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Palliative Care
12.
Asia Pac J Clin Oncol ; 20(1): 87-92, 2024 Feb.
Article En | MEDLINE | ID: mdl-37771144

PURPOSE: Endoscopic ultrasound-guided gastro-enterostomy (EUS-GE) is a relatively novel technique that has been shown to require less re-intervention than standard endoscopic enteral stenting for gastric outlet obstruction and is less invasive, quicker, and more cost-effective than surgery. This study evaluated the outcomes and safety of EUS-GE in patients treated for gastric outlet obstruction across two Australian centers. METHODS: Retrospective data on demographics, presenting symptoms, disease, endoscopic and clinical outcomes, and safety were collected on all patients who underwent EUS-GE from 2021 to 2022. Descriptive statistics were used to evaluate outcomes and safety and survival were calculated using Kaplan-Meier analysis. RESULTS: Eleven patients underwent EUS-GE during the defined period, 10 of whom had a malignant etiology (median age 73 years, interquartile range [IQR] 13; 63.6% male). Technical success was 90.9%. Of those patients, clinical success (the ability to tolerate at least a full liquid diet during follow-up) was 100%. The median length of hospital stay post-procedure was 6 days (IQR 14 days). No severe adverse events occurred, and one patient (10%) required a repeat endoscopy. Median survival post-EUS-GE was 298 days (95% confidence interval 0-730.1 days) CONCLUSION: EUS-GE is an effective, safe, and durable therapy for patients with gastric outlet obstruction. This study presents Australian data on outcomes and safety that is comparable to international literature. EUS-GE should be considered for patients where local expertise allows.


Enterostomy , Gastric Outlet Obstruction , Humans , Male , Aged , Female , Retrospective Studies , Stents/adverse effects , Australia , Gastric Outlet Obstruction/diagnostic imaging , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Endosonography/adverse effects , Endosonography/methods , Ultrasonography, Interventional/adverse effects , Ultrasonography, Interventional/methods , Enterostomy/adverse effects
13.
Clin J Gastroenterol ; 17(1): 52-56, 2024 Feb.
Article En | MEDLINE | ID: mdl-37981629

We report the first case of lumen apposing metal stent (LAMS) use in malignant stricture of the duodenal apex to treat gastric outlet obstruction (GOO) and to facilitate endoscopic retrograde management of synchronous malignant biliary obstruction due to pancreatic head adenocarcinoma. This technique may be an effective alternative and a simpler approach than current methodology to this endoscopically challenging condition.


Cholestasis , Gastric Outlet Obstruction , Pancreatic Neoplasms , Humans , Constriction, Pathologic/etiology , Stents , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Pancreatic Neoplasms/complications , Cholestasis/etiology , Cholestasis/surgery
14.
Surg Laparosc Endosc Percutan Tech ; 33(6): 645-651, 2023 Dec 01.
Article En | MEDLINE | ID: mdl-38053324

BACKGROUND: Patients who have gastric cancer with outlet obstruction (GCOO) and bulky N2 metastases cannot undergo curative resection and tolerate chemotherapy poorly, which may be improved by multimodality therapy (MMT) combined with laparoscopic gastrectomy. PATIENTS AND METHODS: The records of patients with GCOO and bulky N2 metastases who received MMT including nasojejunal feeding combined with preoperative chemotherapy (PCT), followed by laparoscopic exploration [enteral nutritional (EN) group] in sequence or laparoscopic gastrojejunostomy (LGJ) before PCT plus laparoscopic gastrectomy (LGJ group) were retrospectively reviewed. Prognostic Nutritional Index, gastric outlet obstruction scoring system grade, quality of life, response to PCT, surgical outcomes, and long-term survival were analyzed. RESULTS: Fifty-four consecutive patients with GCOO and bulky N2 metastases were identified. The Prognostic Nutritional Index and Nutritional Risk Screening-2002 score of patients were significantly improved as a result of multimodal therapy, but no superiority was demonstrated between the EN group and the LGJ group. The quality of life (52.6 ± 11.4 vs 68.2 ± 13.5, P = 0.036) and gastric outlet obstruction scoring system (P < 0.05) of patients in the LGJ group were better compared with the EN group. The rate of laparoscopic D2 gastrectomy (94.3% vs 92.9%, P = 0.64) and R0 resection (91.4% vs 92.9%, P = 0.53) in the EN group was similar to the LGJ group. There were no significant differences for the 5-year overall survival rate (63.2% vs 57.1, P = 0.86) and the 5-year relapse-free survival rate (42.9% vs 53.8%, P = 0.54) of patients in the EN group compared with the LGJ group. CONCLUSIONS: MMT including EN support or laparoscopic gastrojejunostomy followed by laparoscopic D2 gastrectomy is a feasible and effective treatment for patients with GCOO and bulky N2 metastases.


Gastric Outlet Obstruction , Laparoscopy , Stomach Neoplasms , Humans , Stomach Neoplasms/complications , Stomach Neoplasms/surgery , Retrospective Studies , Quality of Life , Neoplasm Recurrence, Local/surgery , Gastrectomy , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery
16.
J Cancer Res Ther ; 19(5): 1430-1432, 2023.
Article En | MEDLINE | ID: mdl-37787322

Gastrointestinal (GI) metastasis from breast carcinoma is a rare occurrence. If metastasis occurs to the stomach/duodenum, it can present with symptoms of gastric outlet obstruction (GOO). Hence, it clinically mimics a variety of benign as well as malignant causes of GOO, including primary malignancy. GI metastasis from breast carcinoma occurs several years after the primary diagnosis and sometimes may be the first presenting symptom. If clinical records are not available, it may be misdiagnosed as poorly differentiated adenocarcinoma on biopsy. A high index of suspicion, subtle histologic clues, and appropriate immunohistochemistry helps in clinching the right diagnosis. Hereby, we report the case of a 55-year-old female who presented with metastasis to the duodenum 8 years post mastectomy which mimicked a primary ampullary/periampullary tumor.


Adenocarcinoma , Breast Neoplasms , Gastric Outlet Obstruction , Female , Humans , Middle Aged , Breast Neoplasms/complications , Breast Neoplasms/diagnosis , Breast Neoplasms/pathology , Mastectomy/adverse effects , Gastric Outlet Obstruction/diagnosis , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Adenocarcinoma/surgery , Biopsy
17.
Am J Case Rep ; 24: e940661, 2023 Oct 09.
Article En | MEDLINE | ID: mdl-37807466

BACKGROUND Recent developments in surgical suture material include the use of sutures with unidirectional barbs that facilitate laparoscopic suturing thanks to self-anchoring and tension-keeping properties. Complications deriving from the use of barbed sutures have been previously reported. In this report we present the case of a patient with gastric outlet obstruction by the free end of a V-Loc™ barbed suture (Medtronic, Dublin, Ireland) following Roux-en-Y gastric resection. CASE REPORT In February 2023, a 77-year-old man who underwent laparoscopic subtotal gastrectomy for cancer followed by Roux-en-Y reconstruction developed symptoms of gastric outlet obstruction a few days after discharge. The patient was readmitted to the hospital due to vomiting 4 days after being discharged after an uneventful postoperative course. Imaging confirmed the presence of an occlusion at the level of the jejunojejunal anastomosis, with a noticeable change in caliber. During laparoscopy, a loop of bowel was entrapped around the tail of the barbed suture used to close the common enterotomy of jejunojejunal anastomosis. Following laparoscopic division of the anchoring suture, the bowel regained its normal caliber. CONCLUSIONS Although complications from the use of unidirectional barbed surgical sutures are rare, this report highlights bowel obstruction as a recognized postoperative complication. The preferred treatment is laparoscopic division of the suture's tail. To prevent complications related to barbed sutures, it is essential to ensure that all barbs of the suture are properly unfolded.


Gastric Outlet Obstruction , Laparoscopy , Male , Humans , Aged , Suture Techniques/adverse effects , Gastrectomy/adverse effects , Gastrectomy/methods , Laparoscopy/methods , Postoperative Complications/surgery , Postoperative Complications/etiology , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Sutures/adverse effects
18.
BMJ Open ; 13(9): e070735, 2023 09 28.
Article En | MEDLINE | ID: mdl-37770279

INTRODUCTION: Benign gastric outlet obstruction (BGOO) severely impacts the quality of life of patients. The main treatment methods for BGOO include surgery and endoscopy, but both have significant drawbacks. Therefore, this study aims to explore the safety and efficacy of a new technique, to develop a new option for treating BGOO. METHODS AND ANALYSIS: This is an ongoing prospective, single-centre, single-blind randomised controlled trial. The study will be conducted from January 2022 to December 2025, and 50 patients will be enrolled. The participants will be randomly assigned in a 1:1 ratio to either the experimental (stomach-partitioning gastrojejunostomy with distal selective vagotomy) or control groups (conventional gastrojejunostomy with highly selective vagotomy). We will collect baseline characteristics, laboratory tests, auxiliary examinations, operation, postoperative conditions and follow-up data. Follow-up will last for 3 years. The main outcome is the incidence of delayed gastric emptying within 30 days after surgery. Secondary outcomes include the efficacy indicator (consisting of serum gastrin level, pepsinogen level, 13C breath test, gastrointestinal quality of life index, operation time, blood loss and postoperative recovery), a safety evaluation index (consisting of complications and mortality within 30 days after surgery) and follow-up data (consisting of the incidence of primary ulcer progression in 3 years after surgery, and the gastroscopy results in 1 and 3 years after surgery). ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Beijing Friendship Hospital, Capital Medical University (no. 2021-P2-274-02). The study conformed to the provisions of the Declaration of Helsinki (as revised in 2013). Written informed consent will be obtained prior to study enrolment. The results of this study will be published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2100052197.


Gastric Bypass , Gastric Outlet Obstruction , Humans , Vagotomy, Proximal Gastric , Gastric Bypass/adverse effects , Gastric Bypass/methods , Prospective Studies , Quality of Life , Single-Blind Method , Vagotomy/adverse effects , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Treatment Outcome , Randomized Controlled Trials as Topic
19.
Trials ; 24(1): 608, 2023 Sep 25.
Article En | MEDLINE | ID: mdl-37749590

BACKGROUND: Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance status is a laparoscopic surgical gastrojejunostomy (SGJ). Recently, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) emerged as a promising alternative to the surgical approach. The present study aims to compare these treatment modalities in terms of efficacy, safety, and costs. METHODS: The ENDURO-study is a multicentre, open-label, parallel-group randomized controlled trial. In total, ninety-six patients with gastric outlet obstruction caused by an irresectable or metastasized malignancy will be 1:1 randomized to either SGJ or EUS-GE. The primary endpoint is time to tolerate at least soft solids. The co-primary endpoint is the proportion of patients with persisting or recurring symptoms of gastric outlet obstruction for which a reintervention is required. Secondary endpoints are technical and clinical success, quality of life, gastroenterostomy dysfunction, reinterventions, time to reintervention, adverse events, quality of life, time to start chemotherapy, length of hospital stay, readmissions, weight, survival, and costs. DISCUSSION: The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions for persistent or recurrent obstructive symptoms in patients with malignant GOO. This trial aims to guide future treatment strategies and to improve quality of life in a palliative setting. TRIAL REGISTRATION: International Clinical Trials Registry Platform (ICTRP): NL9592. Registered on 07 July 2021.


Gastric Bypass , Gastric Outlet Obstruction , Humans , Gastric Bypass/adverse effects , Endosonography , Quality of Life , Gastric Outlet Obstruction/diagnostic imaging , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
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