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

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2024年10月16日

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

摘要

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).