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. 2024 Oct 16;24(1):314.
doi: 10.1186/s12893-024-02610-0.

The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan

Hayato Baba  1 , Atsushi Oba  1 , Kimitaka Tanaka  2 , Takayuki Miura  3 , Daisuke Ban  4 , Motonori Edanami  5 , Yoshiya Ishikawa  6 , Katsuhisa Ohgi  7 , Haruyoshi Tanaka  8 , Ryuta Shintakuya  9 , Naoki Ikenaga  10 , Tetsuya Ijichi  11 , Yoshitaka Kiya  12 , Ryo Muranushi  13 , So Yamaki  14 , Naoki Miyazaki  15 , Shintaro Takeuchi  2 , Shuichi Aoki  3 , Takahiro Mizui  4 , Masayuki Tanaka  5 , Hiroki Ueda  6 , Hideyuki Dei  7 , Hideki Takami  8 , Kenjiro Okada  9 , Kohei Nakata  10 , Yuko Mataki  11 , Hiroaki Osakabe  12 , Kazuto Shibuya  13 , Daisuke Hashimoto  14 , Yosuke Inoue  1 , Satoshi Hirano  2 , Michiaki Unno  3 , Minoru Esaki  4 , Minoru Kitago  5 , Keiichi Akahoshi  6 , Teiichi Sugiura  7 , Tomoki Ebata  8 , Kenichiro Uemura  9 , Masafumi Nakamura  10 , Takao Otsuka  11 , Yuichi Nagakawa  12 , Tsutomu Fujii  13 , Sohei Satoi  14 , Yu Takahashi  16
Affiliations

The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan

Hayato Baba et al. BMC Surg. .

Abstract

Background: Postoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP.

Methods: This multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C).

Discussion: The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety.

Trial registration: This trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).

Keywords: Distal pancreatectomy; Fibrin glue; Minimally invasive surgery; Pancreatic fistula; Polyglycolic acid mesh.

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Conflict of interest statement

Atsushi Oba has been awarded a grant (Bayer Yakuhin, Ltd.) to conduct an observational study to investigate the clinical impact of EOB-MRI. The other authors have no conflicts of interest to declare. Sohei Satoi declared research fundings from Nihon Servier, Amino-up co. and Boston Scientific.

Figures

Fig. 1
Fig. 1
Flow diagram of the WRAP study
Fig. 2
Fig. 2
The surgical procedure of PGA mesh and fibrin glue reinforcement of the pancreatic stump
Fig. 3
Fig. 3
Study calendar of the WRAP study
See this image and copyright information in PMC

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