Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula

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Abstract

Objectives:

The aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure.

Background:

Several studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump.

Methods:

One hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617).

Results:

Sixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group ( P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ ( P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group ( P = 0.080).

Conclusions:

PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.

Related collections

Most cited references 28

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Distal pancreatectomy: indications and outcomes in 235 patients.

Darren Yeo, Keith Lillemoe, Mark Pitt … (1999)

Distal pancreatectomy is performed for a variety of benign and malignant conditions. In recent years, significant improvements in perioperative results have been observed at high-volume centers after pancreaticoduodenectomy. Little data, however, are available concerning the current indications and outcomes after distal pancreatectomy. This single-institution experience reviews the recent indications, complications, and outcomes after distal pancreatectomy. A retrospective analysis was performed of the hospital records of all patients undergoing distal pancreatectomy between January 1994 and December 1997, inclusive. The patient population (n = 235) had a mean age of 51 years, (range 1 month to 82 years); 43% were male and 84% white. The final diagnoses included chronic pancreatitis (24%), benign pancreatic cystadenoma (22%), pancreatic adenocarcinoma (18%), neuroendocrine tumor (14%), pancreatic pseudocyst (6%), cystadenocarcinoma (3%), and miscellaneous (13%). The level of resection was at or to the left of the superior mesenteric vein in 96% of patients. A splenectomy was performed in 84% and a cholecystectomy in 15% of patients. The median intraoperative blood loss was 450 ml, the median number of red blood cell units transfused was zero, and the median operative time was 4.3 hours. Two deaths occurred in the hospital or within 30 days of surgery for a perioperative mortality rate of 0.9%. The overall postoperative complication rate was 31%; the most common complications were new-onset insulin-dependent diabetes (8%), pancreatic fistula (5%), intraabdominal abscess (4%), small bowel obstruction (4%), and postoperative hemorrhage (4%). Fourteen patients (6%) required a second surgical procedure; the most common indication was postoperative bleeding. The median length of postoperative hospital stay was 10 days. Patients who underwent a distal pancreatectomy with splenectomy (n = 198) had a similar complication rate (30% vs. 29%), operative time (4.6 vs. 5.1 hours), and intraoperative blood loss (500 vs. 350 ml) and a shorter postoperative length of stay (13 vs. 21 days) than the patients who had splenic preservation (n = 37). This series represents the largest single-institution experience with distal pancreatectomy. These data demonstrate that elective distal pancreatectomy is associated with a mortality rate of <1%. These results demonstrate that, as with pancreaticoduodenectomy, distal pancreatectomy can be performed with minimal perioperative mortality and acceptable morbidity.

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Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases.

K Z'graggen, Helmut Friess, Jörg Zehetner … (2007)

The objective of this study was to identify potential risk factors for mortality and morbidity after distal pancreatectomy, with special focus on the formation of pancreatic fistula. Distal pancreatectomy can be performed with low mortality and acceptable morbidity rates. Pancreatic fistulas, occurring in 10% to 20% of cases, remain a problem that contributes significantly to morbidity, length of stay, and overall costs. From November 1993 to February 2006, perioperative and postoperative data of 302 consecutive patients were recorded. Univariate and multivariate analyses of potential risk factors for morbidity and for the formation of pancreatic fistula were performed. The surgical techniques used for closure were categorized into 4 groups: 1) anastomosis, 2) seromuscular patch, 3) closure by suture, and 4) closure using a stapling device. Indications for resection were pancreatic tumors in 62% of patients, nonpancreatic tumors in 23%, chronic pancreatitis in 12%, and others in 3%. The spleen was preserved in 24% of patients. The morbidity and mortality rates for distal pancreatectomy in this series were 35% and 2%, respectively. The prevalence of pancreatic fistula was 12%. Univariate and multivariate analyses indicated that closure using a stapling device and an operating time >or=480 minutes were associated with a higher incidence of pancreatic fistula (odds ratio = 2.6 and 4.2, respectively). Overall morbidity was mainly influenced by the extent of resection (multivisceral vs. conventional; odds ratio = 1.7). Pancreatic leak remains a common complication after distal pancreatectomy. Our series suggests that stapler closure of the pancreatic remnant is associated with a significantly higher fistula rate.

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Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients.

Masaji Tani, Hiroki Yamaue, Hiroshi Terasawa … (2006)

The aim of this study was designed to determine whether the period of drain insertion influences the incidence of postoperative complications. The significance of prophylactic drains after pancreatic head resection is still controversial. No report discusses the association of the period of drain insertion and postoperative complications. A total of 104 consecutive patients who underwent pancreatic head resection were enrolled in this study. To assess the value of prophylactic drains, we prospectively assigned the patients into 2 groups: group I underwent resection from January 2000 to January 2002 (n = 52, drain to be removed on postoperative day 8); group II underwent resection from February 2002 to December 2004 (n = 52, drain to be removed on postoperative day 4). Postoperative complications in the 2 groups were compared. The rate of pancreatic fistula was significantly lower in group II (3.6%) than in group I (23%) (P = 0.0038). The rate of intra-abdominal infections, including intra-abdominal abscess and infected intra-abdominal collections, was significantly reduced in group II (7.7%) compared with group I (38%) (P = 0.0003). Eighteen of 52 (34.6%) patients in group I had an inserted drain beyond 8 days, whereas only 2 of 52 (3.7%) patients in group II had an inserted drain beyond 4 days (P = 0.0002). Cultures of drainage fluid were positive in 16 of 52 (30.8%) patients in group I, and in 2 of 52 (3.7%) patients in group II (P = 0.0002). Intraoperative bleeding (> 1500 mL), operative time (> 420 minutes, and the period of drain insertion were significant risk factors for intra-abdominal infections (P = 0.043, 0.025, 0.0003, respectively). The period of drain insertion was the only independent risk factor for intra-abdominal infections by multivariate analysis (odds ratio, 6.7). Drain removal on postoperative day 4 was shown to be an independent factor in reducing the incidence of complications with pancreatic head resection, including intra-abdominal infections.

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Author and article information

Journal

Journal ID (nlm-ta): Ann Surg

Journal ID (iso-abbrev): Ann. Surg

Journal ID (publisher-id): ANSU

Title: Annals of Surgery

Publisher: Lippincott, Williams, and Wilkins

ISSN (Print): 0003-4932

ISSN (Electronic): 1528-1140

Publication date (Print): July 2016

Publication date (Electronic): 20 November 2015

Volume: 264

Issue: 1

Pages: 180-187

Affiliations

[∗ ]Second Department of Surgery, Wakayama Medical University, Wakayama, Japan

[† ]Department of Surgery, Nara Medical University, Nara, Japan

[‡ ]Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan

[§ ]Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan

[|| ]Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan

[¶ ]Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Hyogo, Japan.

Author notes

Reprints: Hiroki Yamaue, MD, Second Department of Surgery, Wakayama Medical University, School of Medicine, 811–1 Kimiidera, Wakayama 641–8510, Japan. E-mail: yamaue-h@ 123456wakayama-med.ac.jp .

Article

Accession ID: 00028

DOI: 10.1097/SLA.0000000000001395

PMC ID: 4902322

PubMed ID: 26473652

SO-VID: e3839200-e097-4f4e-a634-8be7fe09780a

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0

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Keywords: distal pancreatectomy,pancreatic fistula,pancreaticojejunostomy,stapler closure

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Keywords: distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, stapler closure

Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula

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Most cited references 28

Distal pancreatectomy: indications and outcomes in 235 patients.

Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases.

Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients.

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