荷兰阿姆斯特丹大学的Marja A. Boermeester研究小组取得一项新突破。他们比较了早期手术与内镜优先入路对慢性胰腺炎患者疼痛的影响。该项研究成果发表在2020年1月21日出版的《美国医学会杂志》上。

对于疼痛性慢性胰腺炎患者，往往在内科和内镜治疗失败后，才会进行手术治疗。而观察性研究表明，早期手术可以缓解疾病进展，减轻疼痛，并保持胰腺功能。

为了探讨早期手术是否比内镜优先入路更有效，2011年4月至2016年9月，研究组进行了一项非盲、多中心、随机的临床优势试验，在荷兰30家医院招募了88名慢性胰腺炎患者，均伴有胰腺主管扩张，近期才开始使用阿片类药物镇痛。

将其随机分组，其中44名接受早期手术，6周内行胰管引流术；44名行内窥镜优先入路，接受内科治疗，内窥镜检查并碎石，必要时手术。根据lzbicki疼痛评分对疼痛程度进行评估，0-100分，分数越高越疼痛。研究随访至2018年3月。

88例患者的平均年龄为52岁，女性占24%，共有85例患者完成了试验。在18个月的随访中，早期手术组患者的lzbicki疼痛评分为37分，显著低于内窥镜优先入路组（49分）。随访结束时，早期手术组中有58%的患者疼痛完全或部分缓解，内窥镜优先入路组为39%，差异不显著。早期手术组的干预总次数显著低于内窥镜优先入路组。两组间的并发症、死亡率、住院率、胰腺功能和生活质量均无显著差异。

总之，对于慢性胰腺炎患者，早期手术与内镜优先入路相比，治疗18个月后疼痛评分显著降低。仍需进一步研究来评估长期结局。

附：英文原文

Title: Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial

Author: Yama Issa, Marinus A. Kempeneers, Marco J. Bruno, Paul Fockens, Jan-Werner Poley, Usama Ahmed Ali, Thomas L. Bollen, Olivier R. Busch, Cees H. Dejong, Peter van Duijvendijk, Hendrik M. van Dullemen, Casper H. van Eijck, Harry van Goor, Muhammed Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B. Nieuwenhuijs, Alexander C. Poen, Erik A. Rauws, Adriaan C. Tan, Willem Thijs, Robin Timmer, Ben J. Witteman, Marc G. Besselink, Jeanin E. van Hooft, Hjalmar C. van Santvoort, Marcel G. Dijkgraaf, Marja A. Boermeester

Issue&Volume: 2020/01/21

Abstract:

Importance  For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function.

Objective  To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes.

Design, Setting, and Participants  The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018.

Interventions  There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed.

Main Outcomes and Measures  The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality.

Results  Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, −12 points [95% CI, −22 to −2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach.

Conclusions and Relevance  Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings.

DOI: 10.1001/jama.2019.20967

Source: https://jamanetwork.com/journals/jama/article-abstract/2759004