NEW ORLEANS (EGMN) – Endoscopic ampullectomy had excellent results for early ampullary adenoma, a 3-year multicenter prospective study has shown, and the procedure is now considered the first-line treatment for these early tumors.

The endoscopic procedure is an effective alternative to open surgery, which is quite complicated and often does not provide a complete resection, Dr. Thierry Ponchon said at the annual Digestive Disease Week.

Ampullary tumors are very difficult to treat because of their location at the junction of the common bile duct and duodenum, said Dr. Ponchon, professor of medicine at the Centre Hospitalier Universitaire de Lyon, France. “You must remove the head of the pancreas and the distal part of the duodenum. ... It’s a very complex process for a very small lesion.”

Dr. Ponchon reported 3-year outcomes for 93 consecutive patients with biopsy-positive ampullary adenoma (adenocarcinoma or high- or low-grade dysplasia) who underwent an endoscopic ampullectomy. The patients’ mean age was 57 years (range 13-83 years), and there were 49 females and 44 males. The lesion was considered sporadic in 71 patients, and was related to familial adenomatous polyposis in 22.

Eleven experienced endoscopists performed the operations using a side-viewing endoscope during 2003-2006. Follow-up biopsies were performed between 4 and 8 weeks, when a second resection was performed if necessary; 17 patients had this done. Additional follow-up exams with biopsies took place at 6, 12, 18, 24, and 36 months.

The tumor pathology was adenocarcinoma in 13 patients, high-grade dysplasia in 32, and low-grade dysplasia in 33. One specimen was lost; a second look confirmed that it was an adenoma.

In the remaining 14 patients, the specimen showed no evidence of adenoma despite a previous positive biopsy. “All of these procedures turned out to have been unnecessary,” Dr. Ponchon said. Thus, the rate of false positives was 15%. “We now recommend double biopsies and double histologies for all patients undergoing this procedure.”

Of the 79 patients with confirmed ampullary adenoma, 9 had incomplete resections: 8 with submucosal invasion and 1 with persistent high-grade dysplasia despite repeat treatment. Of these 9 patients, 4 were treated surgically and 5 were treated palliatively. Two patients were not evaluable at 36 months: one had died from acute pancreatitis after surgery, and one was lost to follow-up.

Of the remaining 68 patients, all of whom had a complete resection, 57 were considered cured at 36 months, and 3 had tumor recurrence at 12 months (1 patient) or 24 months (2 patients). Thus the rate of cure at 3 years for patients who had complete resection was 95% (57 of 60 analyzable patients). The other 8 patients had incomplete follow-up (3 patients) or died of other illnesses before the 3-year follow-up (5 patients).

The long-term results after complete resection were excellent, but the study also showed that late recurrence can occur, the authors concluded. Dr. Ponchon cautioned that because of the difficulty of performing an endoscopic ampullectomy, the procedure should be done only by experienced endoscopists.

Dr. Ponchon had no relevant financial disclosures.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

新奥尔良(EGMN) —— 一项为期3年的前瞻性多中心研究结果表明，内镜下壶腹切除术治疗早期壶腹腺瘤的疗效显著，现正在考虑将该手术列为这类早期肿瘤的一线治疗方法。

 

在本年度消化疾病周，Thierry Ponchon博士介绍说，内镜下手术是开放手术的有效替代方法，其手术操作相当复杂，且往往无法完整切除肿瘤。

 

法国里昂大学医学中心的医学教授Ponchon博士说：“壶腹部肿瘤的治疗非常困难，因为其解剖位置处在胆总管和十二指肠连接处，必须切除胰头及十二指肠远端的一部分…...治疗这个很小的病变，其手术过程却非常复杂。”

 

Ponchon博士报告了93例接受内镜下壶腹切除术治疗且活检呈阳性的壶腹部腺瘤[腺癌或高(或低)度不典型增生]患者3年的临床资料。该组病人的平均年龄为57岁(范围：13~83岁)，其中女性患者49名和男性患者44名。这些病变中有71例为散发性的，而22例与家族性腺瘤性息肉病有关。

 

2003~2006年间，该手术由11名经验丰富的内镜医师应用侧视内镜完成。术后4~8周，必要进行第二次切除术时，再次进行活检。共17例患者接受了这样的随访和治疗。另外，在术后6、12、18、24和36个月时也进行了随访活检。

 

13例患者的肿瘤病理为腺癌， 32例为高度不典型增生，33例为低度不典型增生。其中有1例样本丢失，经第二次检查证实为腺瘤。

 

在余下的14例患者中，尽管之前的活检阳性，但其样本中没有发现腺癌的证据。Ponchon博士说：“结果所有这些操作被证实为没必要，其假阳性率为15%，我们现在建议对所有接受这一治疗的患者进行双活检和双重组织学检查。”

 

在这79例被确诊为壶腹部腺瘤的患者中，9例为不完全性切除，8例发生了黏膜下浸润，1例患者尽管接受了再次治疗但仍出现持续高度不典型增生。在这9例患者中，4例接受了外科手术治疗，5例接受了姑息性治疗。术后36个月时，有2名病人没有进行疗效评估：1例死于术后急性胰腺炎，1例失访。

 

余下的68例患者均为完整性切除，在术后36个月时，57例患者被认定为治愈，3例患者肿瘤复发，分别在术后12个月时(1例)和术后24个月(2例)。因此，完整切除术后3年时的治愈率为95%(60例可分析患者中的57例)。另8例随访不完整(3例)或在3年的随访中死于其他疾病(5例)。

 

作者总结说，完全切除术后的长期结果非常好，但研究还表明，后期可能出现复发。Ponchon博士告诫说，考虑到内镜下壶腹切除术的操作难度，该手术应该仅由经验丰富的内镜医师进行操作。

 

Ponchon博士没有相关财务披露。

 

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