Charlotte L van Veldhuisen, Marinus A Kempeneers, Florence E M de Rijk, Stefan A Bouwense, Marco J Bruno, Paul Fockens, Jan W Poley, Usama Ahmed Ali, Thomas L Bollen, Olivier R Busch, Peter van Duijvendijk, Hendrik M van Dullemen, Casper H van Eijck, Harry Van Goor, Muhanned Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B Nieuwenhuijs, Alexander C Poen, Rogier P Voermans, Adriaan C Tan, Willem Thijs, Robert C Verdonk, Ben J Witteman, Jeanin E van Hooft, Hjalmar C van Santvoort, Marcel G Dijkgraaf, Marc G Besselink, Marja A Boermeester, Yama Issa
{"title":"慢性胰腺炎患者早期手术与先行内镜检查的长期疗效对比:ESCAPE随机临床试验的随访分析。","authors":"Charlotte L van Veldhuisen, Marinus A Kempeneers, Florence E M de Rijk, Stefan A Bouwense, Marco J Bruno, Paul Fockens, Jan W Poley, Usama Ahmed Ali, Thomas L Bollen, Olivier R Busch, Peter van Duijvendijk, Hendrik M van Dullemen, Casper H van Eijck, Harry Van Goor, Muhanned Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B Nieuwenhuijs, Alexander C Poen, Rogier P Voermans, Adriaan C Tan, Willem Thijs, Robert C Verdonk, Ben J Witteman, Jeanin E van Hooft, Hjalmar C van Santvoort, Marcel G Dijkgraaf, Marc G Besselink, Marja A Boermeester, Yama Issa","doi":"10.1001/jamasurg.2024.5182","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Patients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.</p><p><strong>Objective: </strong>To compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.</p><p><strong>Design, setting, and participants: </strong>Between April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial. For the present cohort study, long-term clinical data were collected after the initial 18-month follow-up. Follow-up was completed in June 2022, and data analysis was performed in June 2023.</p><p><strong>Exposure: </strong>Patients with chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach.</p><p><strong>Main outcomes and measures: </strong>The primary end point was pain, assessed by the Izbicki pain score; secondary end points included patient-reported complete pain relief and satisfaction. Predefined subgroups included patients who progressed from endoscopy to surgery and those with ductal clearance obtained by endoscopy. Analysis was performed according to the intention-to-treat principle.</p><p><strong>Results: </strong>In this cohort study, 86 of 88 overall patients could be evaluated, with a mean (SD) follow-up period of 98 (16) months. Of 88 initial patients, 21 patients (24%) were female, and mean (SD) patient age was 61 (10) years. At the end of long-term follow-up, the mean (SD) Izbicki pain score was significant lower (33 [31] vs 51 [31]) in the early surgery group, as was the rate of patient-reported complete pain relief (14 of 31 patients [45%] vs 6 of 30 patients [20%]), compared to the endoscopy-first group. After the initial 18-month follow-up, 11 of 43 patients in the early surgery group (26%) underwent reinterventions vs 19 of 43 patients in the endoscopy-first group (44%). At the end of follow-up, more patients in the early surgery group were \"very satisfied\" with their treatment (22 of 31 patients [71%] vs 10 of 30 patients [33%]). Patients who progressed from endoscopy to surgery (22 of 43 patients [51%]) had significantly worse mean (SD) Izbicki pain scores (33 [31] vs 52 [24]) compared to the early surgery group and had a lower rate of complete pain relief (55% for early surgery vs 12% for endoscopy first). In the endoscopy-first group, patients with endoscopic ductal clearance had similar mean (SD) Izbicki pain scores as the remaining patients (49 [34] vs 53 [28]).</p><p><strong>Conclusions and relevance: </strong>In this cohort study evaluating long-term outcomes of the ESCAPE randomized clinical trial, after approximately 8 years of follow-up, early surgery was superior to an endoscopy-first approach in patients with painful chronic pancreatitis and a dilated main pancreatic duct in pain scores and patient satisfaction. Notably, patients who progressed from endoscopy to surgery had worse outcomes compared to patients undergoing early surgery, and obtaining endoscopic ductal clearance did not improve outcomes.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-Term Outcomes of Early Surgery vs Endoscopy First in Chronic Pancreatitis: Follow-Up Analysis of the ESCAPE Randomized Clinical Trial.\",\"authors\":\"Charlotte L van Veldhuisen, Marinus A Kempeneers, Florence E M de Rijk, Stefan A Bouwense, Marco J Bruno, Paul Fockens, Jan W Poley, Usama Ahmed Ali, Thomas L Bollen, Olivier R Busch, Peter van Duijvendijk, Hendrik M van Dullemen, Casper H van Eijck, Harry Van Goor, Muhanned Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B Nieuwenhuijs, Alexander C Poen, Rogier P Voermans, Adriaan C Tan, Willem Thijs, Robert C Verdonk, Ben J Witteman, Jeanin E van Hooft, Hjalmar C van Santvoort, Marcel G Dijkgraaf, Marc G Besselink, Marja A Boermeester, Yama Issa\",\"doi\":\"10.1001/jamasurg.2024.5182\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Patients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.</p><p><strong>Objective: </strong>To compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.</p><p><strong>Design, setting, and participants: </strong>Between April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial. For the present cohort study, long-term clinical data were collected after the initial 18-month follow-up. Follow-up was completed in June 2022, and data analysis was performed in June 2023.</p><p><strong>Exposure: </strong>Patients with chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach.</p><p><strong>Main outcomes and measures: </strong>The primary end point was pain, assessed by the Izbicki pain score; secondary end points included patient-reported complete pain relief and satisfaction. Predefined subgroups included patients who progressed from endoscopy to surgery and those with ductal clearance obtained by endoscopy. Analysis was performed according to the intention-to-treat principle.</p><p><strong>Results: </strong>In this cohort study, 86 of 88 overall patients could be evaluated, with a mean (SD) follow-up period of 98 (16) months. Of 88 initial patients, 21 patients (24%) were female, and mean (SD) patient age was 61 (10) years. At the end of long-term follow-up, the mean (SD) Izbicki pain score was significant lower (33 [31] vs 51 [31]) in the early surgery group, as was the rate of patient-reported complete pain relief (14 of 31 patients [45%] vs 6 of 30 patients [20%]), compared to the endoscopy-first group. After the initial 18-month follow-up, 11 of 43 patients in the early surgery group (26%) underwent reinterventions vs 19 of 43 patients in the endoscopy-first group (44%). At the end of follow-up, more patients in the early surgery group were \\\"very satisfied\\\" with their treatment (22 of 31 patients [71%] vs 10 of 30 patients [33%]). Patients who progressed from endoscopy to surgery (22 of 43 patients [51%]) had significantly worse mean (SD) Izbicki pain scores (33 [31] vs 52 [24]) compared to the early surgery group and had a lower rate of complete pain relief (55% for early surgery vs 12% for endoscopy first). In the endoscopy-first group, patients with endoscopic ductal clearance had similar mean (SD) Izbicki pain scores as the remaining patients (49 [34] vs 53 [28]).</p><p><strong>Conclusions and relevance: </strong>In this cohort study evaluating long-term outcomes of the ESCAPE randomized clinical trial, after approximately 8 years of follow-up, early surgery was superior to an endoscopy-first approach in patients with painful chronic pancreatitis and a dilated main pancreatic duct in pain scores and patient satisfaction. Notably, patients who progressed from endoscopy to surgery had worse outcomes compared to patients undergoing early surgery, and obtaining endoscopic ductal clearance did not improve outcomes.</p>\",\"PeriodicalId\":14690,\"journal\":{\"name\":\"JAMA surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":15.7000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamasurg.2024.5182\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamasurg.2024.5182","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
摘要
重要性:患有疼痛性慢性胰腺炎和胰管扩张的患者可通过早期手术或内镜先行方法进行治疗:利用ESCAPE随机临床试验的随访数据,比较早期手术与内镜先行方法的长期临床疗效:2011年4月至2018年9月期间,作为ESCAPE随机临床试验的一部分,荷兰胰腺炎研究小组(Dutch Pancreatitis Study Group)合作的30家医院将88名疼痛性慢性胰腺炎患者随机分配到早期手术或内镜先行方法治疗。本队列研究在最初的18个月随访后收集了长期临床数据。随访于2022年6月结束,数据分析于2023年6月进行:主要结果和测量指标:主要终点是疼痛,由伊兹比奇疼痛评分评估;次要终点包括患者报告的完全缓解疼痛和满意度。预定义亚组包括从内镜检查进展到手术的患者和内镜检查获得导管清除的患者。分析按照意向治疗原则进行:在这项队列研究中,88 位患者中有 86 位接受了评估,平均(标清)随访时间为 98(16)个月。在 88 名首发患者中,21 名患者(24%)为女性,平均(标清)年龄为 61(10)岁。在长期随访结束时,与先接受内窥镜检查的患者相比,早期手术组患者的平均(标度)伊兹比基疼痛评分显著降低(33 [31] vs 51 [31]),患者报告的疼痛完全缓解率也显著降低(31 例患者中的 14 例 [45%] vs 30 例患者中的 6 例 [20%])。在最初的18个月随访后,早期手术组43名患者中有11人(26%)接受了再干预,而先接受内镜检查组43名患者中有19人(44%)接受了再干预。在随访结束时,早期手术组有更多患者对治疗表示 "非常满意"(31 名患者中有 22 名患者表示 "非常满意"(71%),而 30 名患者中有 10 名患者表示 "非常满意"(33%))。与早期手术组相比,从内镜检查进展到手术的患者(43 例患者中的 22 例[51%])的平均(标度)伊兹比奇疼痛评分(33 [31] vs 52 [24])明显更差,完全缓解疼痛的比例也更低(早期手术为 55% vs 先进行内镜检查为 12%)。在内镜先行组中,内镜下导管清除患者的平均(标度)伊兹比奇疼痛评分与其余患者相似(49 [34] vs 53 [28]):在这项评估ESCAPE随机临床试验长期结果的队列研究中,经过约8年的随访,对于疼痛性慢性胰腺炎和主胰管扩张的患者,早期手术在疼痛评分和患者满意度方面优于先行内镜检查的方法。值得注意的是,与接受早期手术的患者相比,从内镜检查进展到手术的患者预后更差,而且获得内镜下胰管清除并不能改善预后。
Long-Term Outcomes of Early Surgery vs Endoscopy First in Chronic Pancreatitis: Follow-Up Analysis of the ESCAPE Randomized Clinical Trial.
Importance: Patients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.
Objective: To compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.
Design, setting, and participants: Between April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial. For the present cohort study, long-term clinical data were collected after the initial 18-month follow-up. Follow-up was completed in June 2022, and data analysis was performed in June 2023.
Exposure: Patients with chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach.
Main outcomes and measures: The primary end point was pain, assessed by the Izbicki pain score; secondary end points included patient-reported complete pain relief and satisfaction. Predefined subgroups included patients who progressed from endoscopy to surgery and those with ductal clearance obtained by endoscopy. Analysis was performed according to the intention-to-treat principle.
Results: In this cohort study, 86 of 88 overall patients could be evaluated, with a mean (SD) follow-up period of 98 (16) months. Of 88 initial patients, 21 patients (24%) were female, and mean (SD) patient age was 61 (10) years. At the end of long-term follow-up, the mean (SD) Izbicki pain score was significant lower (33 [31] vs 51 [31]) in the early surgery group, as was the rate of patient-reported complete pain relief (14 of 31 patients [45%] vs 6 of 30 patients [20%]), compared to the endoscopy-first group. After the initial 18-month follow-up, 11 of 43 patients in the early surgery group (26%) underwent reinterventions vs 19 of 43 patients in the endoscopy-first group (44%). At the end of follow-up, more patients in the early surgery group were "very satisfied" with their treatment (22 of 31 patients [71%] vs 10 of 30 patients [33%]). Patients who progressed from endoscopy to surgery (22 of 43 patients [51%]) had significantly worse mean (SD) Izbicki pain scores (33 [31] vs 52 [24]) compared to the early surgery group and had a lower rate of complete pain relief (55% for early surgery vs 12% for endoscopy first). In the endoscopy-first group, patients with endoscopic ductal clearance had similar mean (SD) Izbicki pain scores as the remaining patients (49 [34] vs 53 [28]).
Conclusions and relevance: In this cohort study evaluating long-term outcomes of the ESCAPE randomized clinical trial, after approximately 8 years of follow-up, early surgery was superior to an endoscopy-first approach in patients with painful chronic pancreatitis and a dilated main pancreatic duct in pain scores and patient satisfaction. Notably, patients who progressed from endoscopy to surgery had worse outcomes compared to patients undergoing early surgery, and obtaining endoscopic ductal clearance did not improve outcomes.
期刊介绍:
JAMA Surgery, an international peer-reviewed journal established in 1920, is the official publication of the Association of VA Surgeons, the Pacific Coast Surgical Association, and the Surgical Outcomes Club.It is a proud member of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications.