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1.
Neurogastroenterol Motil ; : e14794, 2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38587128

ABSTRACT

BACKGROUND: Peroral endoscopic myotomy (POEM) is an effective and safe treatment for achalasia, but often leads to posttreatment gastroesophageal reflux disease. The aim of this study was to examine the incidence and severity of reflux esophagitis after POEM and to identify associated predictive factors. METHODS: Patients who underwent POEM between August 2011 and December 2022 were included. Multivariate logistic regression was used to assess predictive factors for reflux esophagitis after POEM. KEY RESULTS: In total, 252 patients were included; of which, 46% were female and age ranged between 18 and 87 years. Reflux esophagitis within 1 year after POEM was observed in 131 patients (52%), which was severe in 29 patients (LA grade C/D, 12%). Length of full-thickness myotomy (cm; OR 1.11, 95% CI 1.02-1.21), Eckardt scores before POEM (OR 0.84, 95% CI 0.74-0.96), previous pneumatic dilation (OR 0.51, 95% CI 0.29-0.91), and previous laparoscopic Heller myotomy (LHM; OR 0.44, 95% CI 0.23-0.86) were associated with reflux esophagitis after POEM. Alcohol use (none vs > 7 units per week; OR 3.51, 95% CI 1.35-9.11) and overweight (BMI ≥25 kg/m2; OR 2.67, 95% CI 1.17-6.09) were positive predictive factors and previous LHM (OR 0.13, 95% CI 0.02-0.95) was a negative predictive factor for severe reflux esophagitis after POEM (LA grade C/D). CONCLUSION: About half of the patients develop reflux esophagitis after POEM and 12% is graded as severe. Recognizing predictive factors of reflux esophagitis after POEM treatment leads to better patient selection before POEM and provides an opportunity to take preventive measures or start preemptive treatment.

2.
Am J Gastroenterol ; 2024 Apr 15.
Article in English | MEDLINE | ID: mdl-38619115

ABSTRACT

METHODS: A dataset of the locally treated patients in a randomized controlled trial comparing POEM with pneumatic dilation (PD) was analyzed. A BOM is defined as a >50% increase in esophageal diameter at its widest point in the distal esophagus between the lower esophageal sphincter and 5 cm above. RESULTS: 74 patients were treated in our center, 5-year follow-up data was available in 55 patients (32 (58%) patients randomized to POEM, 23 (42%) PD). In the group initially treated with POEM the incidence of BOM increased from 11.5% (4/38) at three months, 21.1% (8/38) at 1 year, 27.8% (10/36) at 2 years and 31.3% (10/32) at 5 years. None of the patients treated with PD alone developed a BOM. Patients that developed a BOM had higher total Eckardt score and Eckardt regurgitation component compared to patients that underwent POEM without BOM development (3 (2.75-3.25) vs 2 (1.75-3) p=0.032) and (1 (0.75-1 vs 0 (0-1) p=0.041). POEM patients with a BOM more often report reflux symptoms (85% (11/13) vs 46% (2/16), p=0.023) and had a higher acid exposure time ((24.5% (8-47)) vs 6% (1.2-18.7), p=0.027). CONCLUSION: 30% of the patients treated with POEM develop a BOM, which is associated with a higher acid exposure, more reflux symptoms and symptoms of regurgitation.

3.
Article in English | MEDLINE | ID: mdl-38407209

ABSTRACT

BACKGROUND: The management of acute necrotizing pancreatitis (ANP) has changed dramatically over the past 20 years including the use of less invasive techniques, the timing of interventions, nutritional management, and anti-microbial management. This study sought to create a core outcome set (COS) to help shape future research by establishing a minimal set of essential outcomes that will facilitate future comparisons and pooling of data, while minimizing reporting bias. METHODS: A modified Delphi process was performed though involvement of ANP content experts. Each expert proposed a list of outcomes for consideration and the panel anonymously scored the outcomes on a 9-point Likert scale. Core outcome consensus defined a priori as >70% of scores receiving 7-9 points and < 15% of scores receiving 1-3 points. Feedback and aggregate data were shared between rounds with inter-class correlation trends used to determine the end of the study. RESULTS: A total of 19 experts agreed to participate in the study with 16 (84%) participating through study completion. Forty-three outcomes were initially considered with 16 reaching consensuses after four rounds of the modified Delphi process. The final COS included outcomes related to mortality, organ failure, complications, interventions/management, and social factors. CONCLUSION: Through an iterative consensus process, content experts agreed on a COS for the management of ANP. This will help shape future research to generate data suitable for pooling and other statistical analyses that may guide clinical practice. STUDY TYPE: Diagnostic Tests or Criteria. LEVEL OF EVIDENCE: Diagnostic test or criteria, V.

4.
Clin Gastroenterol Hepatol ; 22(1): 62-71.e7, 2024 01.
Article in English | MEDLINE | ID: mdl-37031711

ABSTRACT

BACKGROUND AND AIMS: In high-risk individuals (HRIs), we aimed to assess the cumulative incidence of intraductal papillary mucinous neoplasms (IPMNs) and compare IPMN growth, neoplastic progression rate, and the value of growth as predictor for neoplastic progression to these in sporadic IPMNs. METHODS: We performed annual surveillance of Dutch HRIs, involving carriers of germline pathogenic variants (PVs) and PV-negative familial pancreatic cancer kindreds. HRIs with IPMNs were compared with Italian individuals without familial risk under surveillance for sporadic IPMNs. RESULTS: A total of 457 HRIs were followed for 48 (range 2-172) months; the estimated cumulative IPMN incidence was 46% (95% confidence interval, 28%-64%). In comparison with 442 control individuals, IPMNs in HRIs were more likely to grow ≥2.5 mm/y (31% vs 7%; P < .001) and develop worrisome features (32% vs 19%; P = .010). PV carriers with IPMNs more often displayed neoplastic progression (n = 3 [11%] vs n = 6 [1%]; P = .011), while familial pancreatic cancer kindreds did not (n = 0 [0%]; P = 1.000). The malignancy risk in a PV carrier with an IPMN was 23% for growth rates ≥2.5 mm/y (n = 13), 30% for ≥5 mm/y (n = 10), and 60% for ≥10 mm/y (n = 5). CONCLUSIONS: The cumulative incidence of IPMNs in HRIs is higher than previously reported in the general population. Compared with sporadic IPMNs, they have an increased growth rate. PV carriers with IPMNs are suggested to be at a higher malignancy risk. Intensive follow-up should be considered for PV carriers with an IPMN growing ≥2.5 mm/y, and surgical resection for those growing ≥5 mm/y.


Subject(s)
Adenocarcinoma, Mucinous , Carcinoma, Pancreatic Ductal , Pancreatic Intraductal Neoplasms , Pancreatic Neoplasms , Humans , Incidence , Carcinoma, Pancreatic Ductal/epidemiology , Carcinoma, Pancreatic Ductal/genetics , Carcinoma, Pancreatic Ductal/pathology , Pancreatic Intraductal Neoplasms/epidemiology , Pancreatic Intraductal Neoplasms/genetics , Pancreatic Intraductal Neoplasms/pathology , Pancreatic Neoplasms/pathology , Adenocarcinoma, Mucinous/epidemiology , Adenocarcinoma, Mucinous/genetics , Adenocarcinoma, Mucinous/pathology , Retrospective Studies
5.
Endoscopy ; 56(1): 47-52, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37473780

ABSTRACT

BACKGROUND: This study aimed to assess the safety and feasibility of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent (LAMS) as a primary drainage strategy in patients with distal malignant biliary obstruction (MBO). METHODS: A prospective, single-center, pilot study was conducted in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs), and reinterventions. The study was registered in the Netherlands Trial Registry (registry number NL9757). RESULTS: 22 patients were enrolled (median age 69.5 years [interquartile range 64-75.3]). Technical success was achieved in 20/22 patients (91 %). AEs occurred in one patient, namely perforation following inadequate stent deployment (5 %), which was treated in the same procedure. Clinical success was achieved in 19/22 patients (86 %). Stent dysfunction was observed in 11/20 patients (55 %) after technically successful EUS-CDS: two patients were treated conservatively and nine patients underwent reintervention(s). One patient died within ≤ 30 days due to fulminant disease progression. CONCLUSIONS: The results confirmed the safety and feasibility of EUS-CDS using LAMS as a primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to endoscopic retrograde cholangiopancreatography.


Subject(s)
Choledochostomy , Cholestasis , Drainage , Aged , Humans , Choledochostomy/adverse effects , Choledochostomy/methods , Cholestasis/etiology , Cholestasis/surgery , Drainage/methods , Endosonography/methods , Pilot Projects , Prospective Studies , Stents/adverse effects , Ultrasonography, Interventional/methods
6.
Pancreatology ; 23(8): 942-948, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37866999

ABSTRACT

BACKGROUND/OBJECTIVES: The most important risk factor for recurrent pancreatitis after an episode of acute alcoholic pancreatitis is continuation of alcohol use. Current guidelines do not recommend any specific treatment strategy regarding alcohol cessation. The PANDA trial investigates whether implementation of a structured alcohol cessation support program prevents pancreatitis recurrence after a first episode of acute alcoholic pancreatitis. METHODS: PANDA is a nationwide cluster randomised superiority trial. Participating hospitals are randomised for the investigational management, consisting of a structured alcohol cessation support program, or current practice. Patients with a first episode of acute pancreatitis caused by harmful drinking (AUDIT score >7 and < 16 for men and >6 and < 14 for women) will be included. The primary endpoint is recurrence of acute pancreatitis. Secondary endpoints include cessation or reduction of alcohol use, other alcohol-related diseases, mortality, quality of life, quality-adjusted life years (QALYs) and costs. The follow-up period comprises one year after inclusion. DISCUSSION: This is the first multicentre trial with a cluster randomised trial design to investigate whether a structured alcohol cessation support program reduces recurrent acute pancreatitis in patients after a first episode of acute alcoholic pancreatitis, as compared with current practice. TRIAL REGISTRATION: Netherlands Trial Registry (NL8852). Prospectively registered.


Subject(s)
Pancreatitis, Alcoholic , Male , Humans , Female , Pancreatitis, Alcoholic/therapy , Pancreatitis, Alcoholic/etiology , Quality of Life , Acute Disease , Risk Factors , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
7.
Dig Endosc ; 2023 Oct 18.
Article in English | MEDLINE | ID: mdl-37852797

ABSTRACT

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with lumen apposing metal stent is emerging both as a rescue strategy and a primary treatment for distal malignant biliary obstruction. The large-scale diffusion of the procedure and improved overall survival of patients with pancreatobiliary neoplasms is resulting in a growing population of long-term EUS-CDS lumen apposing metal stent carriers. Recent studies have reported a need for reintervention during follow-up as high as 55%, and the Leuven-Amsterdam-Milan Study Group classification has been developed, identifying five mechanisms of stent dysfunction and 11 possible rescue strategies aimed at restoring biliary drainage. This illustrated technical review aims to further dissect the recent classification through a comprehensive analysis of nine illustrative cases, offering insights into the pathophysiology underlying dysfunction and clinical reasoning behind rescue interventions, as well as technical considerations and practical tips and tricks. By exploring mechanisms of dysfunction, this review also assists clinicians in selecting the ideal candidates for EUS-CDS while identifying patients deemed high risk for dysfunction or clinical failure.

8.
PLoS One ; 18(10): e0286880, 2023.
Article in English | MEDLINE | ID: mdl-37796851

ABSTRACT

INTRODUCTION: Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone and absence of esophageal peristalsis. Achalasia requires invasive treatment in all patients. Conventional treatment options include endoscopic balloon dilation (EBD) and laparoscopic Heller's myotomy (LHM). Recently, a less invasive endoscopic therapy has been developed; Peroral Endoscopic Myotomy (POEM). POEM integrates the theoretical advantages of both EBD and LHM (no skin incisions, less pain, short hospital stay, less blood loss and a durable myotomy). Our aim is to compare efficacy and safety of POEM vs. EBD as primary treatment for achalasia in children. METHODS AND ANALYSIS: This multi-center, and center-stratified block-randomized controlled trial will assess safety and efficacy of POEM vs EBD. Primary outcome measure is the need for retreatment due to treatment failure (i.e. persisting symptoms (Eckardt score > 3) with evidence of recurrence on barium swallow and/or HRM within 12 months follow-up) as assed by a blinded end-point committee (PROBE design). DISCUSSION: This RCT will be the first one to evaluate which endoscopic therapy is most effective and safe for treatment of naïve pediatric patients with achalasia.


Subject(s)
Esophageal Achalasia , Myotomy , Natural Orifice Endoscopic Surgery , Humans , Child , Esophageal Achalasia/surgery , Esophageal Achalasia/diagnosis , Dilatation/methods , Natural Orifice Endoscopic Surgery/methods , Esophageal Sphincter, Lower/surgery , Treatment Outcome , Myotomy/methods , Esophagoscopy/methods , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
9.
Trials ; 24(1): 608, 2023 Sep 25.
Article in English | MEDLINE | ID: mdl-37749590

ABSTRACT

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.


Subject(s)
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
13.
Ann Surg ; 2023 Jul 17.
Article in English | MEDLINE | ID: mdl-37450701

ABSTRACT

OBJECTIVE: To compare the long-term outcomes of immediate drainage versus the postponed drainage approach in patients with infected necrotizing pancreatitis. SUMMARY BACKGROUND DATA: In the randomized POINTER trial, patients assigned to the postponed-drainage approach using antibiotic treatment required fewer interventions, as compared to immediate drainage, and over a third were treated without any intervention. METHODS: Clinical data of those patients alive after the initial 6-month follow-up were re-evaluated. Primary outcome was a composite of death and major complications. RESULTS: Out of 104 patients, 88 were re-evaluated with a median follow-up of 51 months. After the initial 6-month follow-up, the primary outcome occurred in 7 of 47 patients (15%) in the immediate-drainage group and 7 of 41 patients (17%) in the postponed-drainage group (RR 0.87, 95% CI 0.33-2.28; P =0.78). Additional drainage procedures were performed in 7 patients (15%) versus 3 patients (7%) (RR 2.03; 95% CI 0.56-7.37; P =0.34). The median number of additional interventions was 0 (IQR 0-0) in both groups ( P =0.028). In the total follow-up, the median number of interventions was higher in the immediate-drainage group than in the postponed-drainage group (4 vs. 1, P =0.001). Eventually, 14 of 15 patients (93%) in the postponed-drainage group who were successfully treated in the initial 6-month follow-up with antibiotics and without any intervention, remained without intervention. At the end of follow-up, pancreatic function and quality of life were similar. CONCLUSIONS: Also during long-term follow-up, a postponed drainage approach using antibiotics in patients with infected necrotizing pancreatitis results in fewer interventions as compared to immediate drainage, and should therefore be the preferred approach. TRIAL REGISTRATION: ISRCTN33682933.

15.
Endosc Int Open ; 11(5): E546-E552, 2023 May.
Article in English | MEDLINE | ID: mdl-37251790

ABSTRACT

Background and study aims Epiphrenic diverticula are rare and mainly occur in patients with underlying esophageal motility disorders. The current standard treatment is surgical diverticulectomy often combined by myotomy and is associated with significant adverse event (AE) rates. The aim of this study was to examine the efficacy and safety of peroral endoscopic myotomy in reducing esophageal symptoms in patients with esophageal diverticula. Patients and methods We performed a retrospective cohort study including patients with an esophageal diverticulum who underwent POEM between October 2014 and December 2022. After informed consent, data were extracted from medical records and patients completed a survey by telephone. The primary outcome was treatment success, defined as Eckardt score below 4 with a minimal reduction of 2 points. Results Seventeen patients (mean age 71 years, 41.2 % female) were included. Achalasia was confirmed in 13 patients (13 /17, 76.5 %), Jackhammer esophagus in two patients (2 /17, 11.8 %), diffuse esophageal spasm in one patient (1 /17, 5.9 %) and in one patient no esophageal motility disorder was found (1 /17, 5.9 %). Treatment success was 68.8 % and only one patient (6.3 %) underwent retreatment (pneumatic dilatation). Median Eckardt scores decreased from 7 to 1 after POEM (p < 0.001). Mean size of the diverticula decreased from 3.6 cm to 2.9 cm after POEM (p < 0.001). Clinical admission was one night for all patients. AEs occurred in two patients (11.8 %) which were classified as grade II and IIIa (AGREE classification). Conclusions POEM is effective and safe to treat patients with esophageal diverticula and an underlying esophageal motility disorder.

16.
Neurogastroenterol Motil ; 35(8): e14614, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37246930

ABSTRACT

BACKGROUND & AIMS: The aim of the study was to evaluate the effect of an electronic positional therapy wearable device on nocturnal gastroesophageal reflux measured by pH-impedance reflux monitoring. METHODS: We performed a single-center, prospective, interventional study in 30 patients with nocturnal reflux symptoms and a nocturnal esophageal acid exposure time (AET) ≥1.5% measured off acid-suppressive medication by ambulatory pH-impedance reflux monitoring. Patients were treated with an electronic positional therapy wearable device for 2 weeks. The device vibrates in the right lateral decubitus position so it conditions patients to avoid that sleep position. After 2 weeks treatment, the pH-impedance study was repeated. Primary outcome was the change in nocturnal AET. Secondary outcomes include change in number of reflux episodes and reflux symptoms. RESULTS: Complete data were available for 27 patients (13 females, mean age 49.8 years). The median nocturnal AET decreased from 6.0% (IQR, 2.3-15.3) to 3.1% (0.1-10.8) after 2 weeks of treatment (p = 0.079). The number of reflux episodes was significantly reduced after 2 weeks of treatment (baseline: 8.0 (3.0-12.3) vs. end: 3.0 (1.0-8.0); p = 0.041). Treatment led to a statistically significant decrease in time spent in right lateral decubitus position (baseline: mean 36.9% ± 15.2% vs. end: 2.7% ± 8.2%; p = <0.001) and an increase in the left lateral decubitus position (baseline 29.2% ± 14.8% vs. end: 63.3% ± 21.9%; p = <0.001). Symptom improvement was reported by 70.4% of the patients. CONCLUSIONS: Sleep positional therapy using an electronic wearable device promotes sleeping in the left lateral decubitus position and improves reflux parameters measured by pH-impedance reflux monitoring.


Subject(s)
Esophageal pH Monitoring , Gastroesophageal Reflux , Female , Humans , Middle Aged , Prospective Studies , Electric Impedance , Gastroesophageal Reflux/diagnosis , Hydrogen-Ion Concentration , Proton Pump Inhibitors/therapeutic use
17.
Endoscopy ; 55(9): 812-819, 2023 09.
Article in English | MEDLINE | ID: mdl-37019154

ABSTRACT

BACKGROUND : High quality colonoscopy is fundamental to good patient outcomes. "Textbook outcome" has proven to be a feasible multidimensional measure for quality assurance between surgical centers. In this study, we sought to establish the "textbook process" (TP) as a new composite measure for the optimal colonoscopy process and assessed how frequently TP was attained in clinical practice and the variation in TP between endoscopists. METHODS : To reach consensus on the definition of TP, international expert endoscopists completed a modified Delphi consensus process. The achievement of TP was then applied to clinical practice. Prospectively collected data in two endoscopy services were retrospectively evaluated. Data on colonoscopies performed for symptoms or surveillance between 1 January 2018 and 1 August 2021 were analyzed. RESULTS : The Delphi consensus process was completed by 20 of 27 invited experts (74.1 %). TP was defined as a colonoscopy fulfilling the following items: explicit colonoscopy indication; successful cecal intubation; adequate bowel preparation; adequate withdrawal time; acceptable patient comfort score; provision of post-polypectomy surveillance recommendations in line with guidelines; and the absence of the use of reversal agents, early adverse events, readmission, and mortality. In the two endoscopy services studied, TP was achieved in 5962/8227 colonoscopies (72.5 %). Of 48 endoscopists performing colonoscopy, attainment of TP varied significantly, ranging per endoscopist from 41.0 % to 89.1 %. CONCLUSION : This study proposes a new composite measure for colonoscopy, namely "textbook process." TP gives a comprehensive summary of performance and demonstrates significant variation between endoscopists, illustrating the potential benefit of TP as a measure in future quality assessment programs.


Subject(s)
Cecum , Colonoscopy , Humans , Colonoscopy/methods , Quality Indicators, Health Care , Retrospective Studies , Intestines
18.
HPB (Oxford) ; 25(7): 798-806, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37059650

ABSTRACT

BACKGROUND: For palliative drainage of inoperable perihilar cholangiocarcinoma (pCCA) uncovered metal stents are preferred over plastic stents. However, there is a lack of data on re-interventions at the long-term. The aim is to evaluate the potential difference in the number of re-interventions in patients surviving at least 6 months. METHODS: Retrospective study including patients with pCCA who underwent plastic stent placement(s) or had metal stent(s) in situ for at least 6 months. The primary outcome was the number of re-interventions per patient-year. A propensity score matching (1:1) analysis was performed using age, Bismuth classification, reason for inoperability, pathological confirmation, systemic therapy and initial approach (endoscopic vs percutaneous). RESULTS: Patients in the metal stent group (n = 87) underwent fewer re-interventions compared with the plastic stent group (n = 40) (3.0 vs. 4.7 per patient-year; IRR, 0.64; 95% CI, 0.47 to 0.88). When only non-elective re-interventions were included, there was no significant difference (2.1 vs. 2.7; IRR, 0.76; 95% CI, 0.55 to 1.08). Results were similar in the propensity score-matched dataset. CONCLUSIONS: This study shows that, also in patients with inoperable pCCA who survive at least 6 months, placement of metal stent(s) leads to fewer re-interventions in comparison with plastic stents.


Subject(s)
Bile Duct Neoplasms , Cholangiocarcinoma , Klatskin Tumor , Humans , Klatskin Tumor/surgery , Retrospective Studies , Propensity Score , Bile Duct Neoplasms/surgery , Bile Duct Neoplasms/pathology , Stents , Metals , Plastics , Palliative Care/methods , Treatment Outcome
19.
Gastroenterology ; 164(7): 1108-1118.e3, 2023 06.
Article in English | MEDLINE | ID: mdl-36907524

ABSTRACT

BACKGROUND & AIMS: For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM. METHODS: This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment. RESULTS: Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015). CONCLUSIONS: Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis. NETHERLANDS TRIAL REGISTRY: NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.


Subject(s)
Esophageal Achalasia , Esophagitis, Peptic , Heller Myotomy , Natural Orifice Endoscopic Surgery , Humans , Esophageal Achalasia/diagnosis , Esophageal Achalasia/surgery , Heller Myotomy/adverse effects , Heller Myotomy/methods , Esophageal Sphincter, Lower/surgery , Dilatation/adverse effects , Dilatation/methods , Barium , Treatment Outcome , Esophagitis, Peptic/diagnosis , Esophagitis, Peptic/etiology , Esophagitis, Peptic/therapy , Natural Orifice Endoscopic Surgery/adverse effects , Natural Orifice Endoscopic Surgery/methods
20.
Pancreatology ; 23(3): 251-257, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36805049

ABSTRACT

BACKGROUND: Follow-up in patients with intraductal papillary mucinous neoplasm (IPMN) aims to detect advanced neoplasia (high-grade dysplasia/cancer) in an early stage. The 2015 American Gastroenterological Association (AGA), 2017 International Association of Pancreatology (IAP), and the 2018 European Study Group on Cystic tumours of the Pancreas (European) guidelines differ in their recommendations on indications for surgery. However, it remains unclear which guideline is most accurate in predicting advanced neoplasia in IPMN. METHODS: Patients who underwent surgery were extracted from a prospective database (January 2006-January 2021). In patients with IPMN, final pathology was compared with the indication for surgery according to the guidelines. ROC-curves were calculated to determine the diagnostic accuracy for each guideline. RESULTS: Overall, 247 patients underwent surgery for cystic lesions. In 145 patients with IPMN, 52 had advanced neoplasia, of which the AGA guideline would have advised surgery in 14 (27%), the IAP and European guideline in 49 (94%) and 50 (96%). In 93 patients without advanced neoplasia, the AGA, IAP, and European guidelines would incorrectly have advised surgery in 8 (8.6%), 77 (83%) and 71 (76%). CONCLUSION: The European and IAP guidelines are clearly superior in detecting advanced neoplasia in IPMN as compared to the AGA, albeit at the cost of a higher rate of unnecessary surgery. To harmonize care and to avoid confusion caused by conflicting statements, a global evidence-based guideline for PCN in collaboration with the various guidelines groups is required once the current guidelines require an update.


Subject(s)
Carcinoma, Pancreatic Ductal , Neoplasms, Cystic, Mucinous, and Serous , Pancreatic Cyst , Pancreatic Intraductal Neoplasms , Pancreatic Neoplasms , Humans , Pancreatic Intraductal Neoplasms/diagnosis , Pancreatic Intraductal Neoplasms/surgery , Pancreatic Intraductal Neoplasms/pathology , Pancreatic Cyst/diagnosis , Pancreatic Cyst/surgery , Pancreatic Cyst/pathology , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/surgery , Pancreatic Neoplasms/pathology , Pancreas/pathology , Carcinoma, Pancreatic Ductal/diagnosis , Carcinoma, Pancreatic Ductal/surgery , Carcinoma, Pancreatic Ductal/pathology , Retrospective Studies
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