可吸收高分子组织密封膜在胰体尾切除术中的应用

doi:10.3877/cma.j.issn.2095-3232.2026.05.009

目的

探讨可吸收高分子组织密封膜在胰体尾切除术中的应用价值。

方法

本研究对象为2023年4月至2025年4月于解放军总医院第七医学中心肝胆外科行胰体尾切除的49例患者。患者均签署知情同意书，符合医学伦理学规定。其中男33例，女16例；年龄37~77岁，中位年龄59岁。采用随机数表法随机分为密封膜组（24例）和对照组（25例）。密封膜组术中切割闭合器闭合并离断胰腺后应用TissuePatch^TM膜贴敷胰腺残端，对照组胰腺断端创面不做任何处理。两组手术时间、术中出血量、术后引流量、引流液淀粉酶、排气时间、引流管留置时间、术后住院时间等比较采用Mann-Whitney U检验。并发症发生率等比较采用χ²检验或Fisher确切概率法。

结果

密封膜组术后3 d引流液淀粉酶水平为488（43~7 932） U/L，明显低于对照组的2 933（148~61 614） U/L（Z=-2.87，P=0.004）。密封膜组术后排气时间、引流管留置时间、术后住院时间分别为48（24~72） h、8（6~39） d、8（5~15） d，均明显短于对照组的72 （24~120） h、15（6~77） d、9（5~37） d（Z=-2.39、-2.51、-1.98；P<0.05）。密封膜组和对照组术后并发症发生率分别为25%（6/24）、28%（7/25），差异无统计学意义（χ²=0.06，P=0.803）。密封膜组A级、B级胰瘘分别为8、4例，对照组相应为10、5例，均无C级胰瘘和二次手术，两组胰瘘临床分级比较差异无统计学意义（P=0.832）。密封膜组无使用TissuePatch^TM膜相关的并发症，包括不耐受或排斥反应。

结论

胰体尾切除术中使用可吸收高分子组织密封膜，可以减少胰液的渗出，缩短引流管留置时间及术后住院时间，有利于术后快速恢复。

关键词: 胰腺切除术, 胰瘘, 预防, 加速康复外科

Objective

To investigate the application value of absorbable polymer tissue sealing film in distal pancreatectomy.

Methods

The study included 49 patients who underwent distal pancreatectomy in the Department of Hepatobiliary Surgery of the Seventh Medical Center of Chinese PLA General Hospital from April 2023 to April 2025. The informed consents of all patients were obtained and the local ethical committee approval was received. Among them, 33 patients were male and 16 were female, aged from 37 to 77 years, with a median age of 59 years. The patients were randomly divided into the sealing film group (n=24) and the control group (n=25) using a random number table. In the sealing film group, TissuePatch^TM was applied to the pancreatic stump after transection of the pancreas using a linear stapler during surgery, while the pancreatic stump wound in the control group was left untreated. Operative time, intraoperative blood loss, postoperative drainage volume, amylase level in the drainage fluid, time to flatus, duration of drainage tube placement, and postoperative length of hospital stay were compared between the two groups using the Mann-Whitney U test. The incidence of complications and other categorical variables were compared using the Chi-square test or Fisher's exact test.

Results

The amylase level on postoperative day 3 in the sealing film group was 488 (43-7 932) U/L, which was significantly lower than 2 933 (148-61 614) U/L in the control group (Z=-2.87, P=0.004). The time to flatus, duration of drainage tube placement, and postoperative length of hospital stay in the sealing film group were 48 (24-72) h, 8 (6-39) d, and 8 (5-15) d, respectively, all of which were significantly shorter than 72 (24-120) h, 15 (6-77) d, and 9 (5-37) d in the control group (Z=-2.39,-2.51, and -1.98; P<0.05). The postoperative complication rates in the sealing film group and the control group were 25% (6/24) and 28% (7/25), respectively, with no statistically significant difference (χ²=0.06, P=0.803). There were 8 cases of grade A pancreatic fistula and 4 cases of grade B pancreatic fistula in the sealing film group, compared with 10 and 5 cases in the control group, respectively. No grade C pancreatic fistula or reoperation occurred in either group, and there was no statistically significant difference in the clinical grading of pancreatic fistula between the two groups (P=0.832). No TissuePatch^TM-related complications, including intolerance or rejection, occurred in the sealing film group.

Conclusions

The use of absorbable polymer tissue sealing film during distal pancreatectomy can reduce pancreatic fluid leakage, shorten the duration of drainage tube placement and postoperative length of hospital stay, and facilitate rapid postoperative recovery.

Key words: Pancreatectomy, Pancreatic fistula, Prevention, Enhanced recovery after surgery (ERAS)

图1 一例DP患者术中用TissuePatch^TM膜敷贴胰腺横断面注：a为TissuePatch^TM膜；b为胰腺残端；c为胰腺残端放置TissuePatch^TM膜；DP为胰体尾切除术

表1 两组DP患者术前基线资料比较

组别	例数	年龄[岁, M(Min~Max)]	性别(例)		原发病(例)		BMI[kg/m², M(Min~Max)]	合并糖尿病(例)	胰管直径(mm)	饮酒史(例)	吸烟史(例)
组别	例数	年龄[岁, M(Min~Max)]	男	女	恶性	良性	BMI[kg/m², M(Min~Max)]	合并糖尿病(例)	胰管直径(mm)	饮酒史(例)	吸烟史(例)
密封膜组	24	59(37~74)	16	8	12	12	23.5(20.1~28.4)	6	3.5(2.0~7.0)	8	10
对照组	25	60(44~77)	17	8	11	14	24.1(21.0~29.0)	7	4.0(2.0~8.0)	9	12
统计值		Z=0.47	χ²=0.010		χ²=0.182		Z=0.325	χ²=0.812	Z=0.278	χ²=0.711	χ²=0.689
P值		0.639	0.920		0.670		0.745	0.367	0.781	0.401	0.407

表1 两组DP患者术前基线资料比较

组别	例数	年龄[岁, M(Min~Max)]	性别(例)		原发病(例)		BMI[kg/m², M(Min~Max)]	合并糖尿病(例)	胰管直径(mm)	饮酒史(例)	吸烟史(例)
组别	例数	年龄[岁, M(Min~Max)]	男	女	恶性	良性	BMI[kg/m², M(Min~Max)]	合并糖尿病(例)	胰管直径(mm)	饮酒史(例)	吸烟史(例)
密封膜组	24	59(37~74)	16	8	12	12	23.5(20.1~28.4)	6	3.5(2.0~7.0)	8	10
对照组	25	60(44~77)	17	8	11	14	24.1(21.0~29.0)	7	4.0(2.0~8.0)	9	12
统计值		Z=0.47	χ²=0.010		χ²=0.182		Z=0.325	χ²=0.812	Z=0.278	χ²=0.711	χ²=0.689
P值		0.639	0.920		0.670		0.745	0.367	0.781	0.401	0.407

表2 两组DP患者手术情况比较

组别	例数	手术方式(例)			保留脾脏(例)	联合脏器切除(例)	手术时间[min, M(Min~Max)]	出血量[ml, M(Min~Max)]
组别	例数	开腹	腹腔镜	机器人	保留脾脏(例)	联合脏器切除(例)	手术时间[min, M(Min~Max)]	出血量[ml, M(Min~Max)]
密封膜组	24	8	7	9	14	7	210(110~310)	50(20~700)
对照组	25	8	10	7	14	9	230(110~420)	80(10~800)
统计值		χ²=0.528			χ²=0.042	χ²=0.236	Z=-1.724	Z=-1.839
P值		0.726			0.838	0.627	0.085	0.066

表2 两组DP患者手术情况比较

组别	例数	手术方式(例)			保留脾脏(例)	联合脏器切除(例)	手术时间[min, M(Min~Max)]	出血量[ml, M(Min~Max)]
组别	例数	开腹	腹腔镜	机器人	保留脾脏(例)	联合脏器切除(例)	手术时间[min, M(Min~Max)]	出血量[ml, M(Min~Max)]
密封膜组	24	8	7	9	14	7	210(110~310)	50(20~700)
对照组	25	8	10	7	14	9	230(110~420)	80(10~800)
统计值		χ²=0.528			χ²=0.042	χ²=0.236	Z=-1.724	Z=-1.839
P值		0.726			0.838	0.627	0.085	0.066

表3 两组DP患者术后情况比较[M（Min~Max）]

组别	例数	术后3 d引流量(ml)	术后3 d引流液淀粉酶(U/L)	排气时间(h)	引流管留置时间(d)	术后住院时间(d)
密封膜组	24	50(5~200)	488(43~7 932)	48(24~72)	8(6~39)	8(5~15)
对照组	25	50(10~280)	2 933(148~61 614)	72(24~120)	15(6~77)	9(5~37)
Z值		-0.73	-2.87	-2.39	-2.51	-1.98
P值		0.463	0.004	0.017	0.012	0.048

表3 两组DP患者术后情况比较[M（Min~Max）]

组别	例数	术后3 d引流量(ml)	术后3 d引流液淀粉酶(U/L)	排气时间(h)	引流管留置时间(d)	术后住院时间(d)
密封膜组	24	50(5~200)	488(43~7 932)	48(24~72)	8(6~39)	8(5~15)
对照组	25	50(10~280)	2 933(148~61 614)	72(24~120)	15(6~77)	9(5~37)
Z值		-0.73	-2.87	-2.39	-2.51	-1.98
P值		0.463	0.004	0.017	0.012	0.048

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Application value of absorbable polymer tissue sealing film in distal pancreatectomy

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Application value of absorbable polymer tissue sealing film in distal pancreatectomy