Shark Mouth Pancreaticojejunostomy: A New Enteric Reconstruction Procedure of Pancreatic Stump

Shark Mouth Pancreaticojejunostomy: A New Enteric Reconstruction Procedure of Pancreatic Stump

Pancreaticoduodenectomy, one of the most complex surgical procedures, remains a standard therapy for benign and malignant lesions of the pancreatic head and periampullary region. Despite advancements in surgical techniques and perioperative management, the mortality rate has been reduced to less than 3% in high-volume surgery centers. However, the incidence of postoperative complications remains high, ranging from 30% to 50%, with pancreatic fistula rates varying between 5% and 40%. Postoperative pancreatic fistula (POPF), particularly clinically relevant (CR)-POPF, is a life-threatening complication that can lead to intra-abdominal abscess, hemorrhage, and sepsis. The mortality rate escalates significantly if POPF-related hemorrhage occurs.

The exocrine output from the pancreatic remnant is widely implicated as the initial promoter of fistula. Continuous leakage of caustic proteases and lipolytic enzymes can cause significant local consequences such as abscess, pancreatic fistula, pseudoaneurysm, and hemorrhage, as well as systemic sequelae like sepsis and shock. Risk factors for CR-POPF include higher body mass index, thinner main pancreatic duct, soft gland texture, and the surgical procedure itself. Among these, only the surgical procedure can be improved by surgeons. Therefore, developing an easy, feasible, and efficient method to avoid CR-POPF is crucial, particularly in improving the enteric reconstruction technique of the pancreatic stump.

Various techniques for enteric reconstruction have been proposed, including invagination pancreaticojejunostomy, binding pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, Roux-en-Y pancreaticojejunostomy, and pancreaticogastrostomy. Each technique has its advantages and disadvantages. Despite the introduction of several anastomotic techniques aimed at reducing the incidence of pancreatic fistula, large prospective studies and meta-analyses have shown no significant differences in postoperative complications and mortality among these methods. Invagination pancreaticojejunostomy and duct-to-mucosa pancreaticojejunostomy remain the most popular reconstruction procedures. However, invagination pancreaticojejunostomy is difficult to perform in cases of larger pancreatic remnants and soft glands, while duct-to-mucosa pancreaticojejunostomy is challenging in cases of thinner pancreatic ducts. Incomplete drainage of the pancreatic remnant is also considered an important reason for CR-POPF.

To address these challenges, a new procedure named “shark mouth pancreaticojejunostomy” has been developed. This technique aims to facilitate pancreaticojejunostomy with theoretical advantages, particularly in reducing the rate of complications, especially POPF. The study aims to evaluate the efficacy of this new procedure, hypothesizing that it will reduce the fistula rate from around 20% to less than 10%.

The study is a prospective single-arm observational clinical trial conducted at the Department of General Surgery, Peking University Third Hospital. Patients diagnosed with pancreatic cancer or other diseases requiring pancreaticoduodenectomy are recruited. The primary endpoint is the incidence rate of POPF, while secondary endpoints include anastomosis time, postoperative hospital stay, and other morbidities such as hemorrhage. The study plans to enroll 120 patients, ensuring a power of 80% at a two-sided significance level of 5%, assuming a 10% withdrawal rate.

Inclusion criteria for the study are patients diagnosed with pancreatic cancer or other diseases requiring pancreaticoduodenectomy, who are operation-tolerant and have provided informed consent. Exclusion criteria include a history of abdominal operation, cases where pancreaticoduodenectomy is abandoned during surgery, patients who choose to exit the study, and pregnancy.

The “shark mouth pancreaticojejunostomy” procedure involves several key steps. The remnant of the jejunum is closed by continuous suture. A transverse incision is made on the posterior wall of the jejunum, starting 0.2 cm from the mesenteric border and not exceeding the anti-mesenteric border. In cases of a large pancreatic remnant, a longitudinal incision is made at the anterior part of the anastomosis. The posterior part of the anastomosis consists of two layers of intermittent sutures, including a seromuscular suture layer and a full-thickness suture layer. The anterior part of the anastomosis is a single-layer full-thickness suture. Finally, the seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of the anastomosis.

Concomitant therapies, including the use of somatostatin, somatostatin analogs, antibiotics, and acid inhibitors, are recorded. The primary endpoint of POPF is evaluated according to the International Study Group of Pancreatic Surgery (ISGPS) classification. Secondary endpoints, including anastomosis time, morbidities besides POPF, and postoperative hospital stay, are also assessed. Anastomosis time is defined as the time from the beginning to the end of the shark mouth pancreaticojejunostomy procedure. Morbidities are classified according to the Clavien-Dindo definition, and postoperative hospital stay is defined as the length of hospital stay after the operation.

Statistical analysis involves entering clinical data, including adverse events, concomitant medications, and expected adverse reactions, into the record system provided by the Ethics Committee of Peking University Third Hospital. Categorical data are presented as numbers with percentages, and continuous data are presented as means with standard deviations or medians with ranges. Subgroup analyses are based on age, gender, pancreas texture, diameter of the main pancreatic duct, and primary diseases. A two-tailed P < 0.05 is considered statistically significant, and SPSS for Windows version 19.0 is used for analysis.

The shark mouth pancreaticojejunostomy technique offers several advantages over previously reported procedures. First, it reduces the tension of the anastomotic stoma through multiple layers of sutures. Second, it creates a wide contact surface between the pancreatic remnant and the jejunum. Third, the serosa of the pancreatic capsule is directly anastomosed to the serosa of the small intestine wall, aligning with the alimentary tissue healing process. Fourth, it is technically easier to perform in cases of soft, friable, and fatty pancreas with a thinner duct compared to duct-to-mucosa anastomosis.

In summary, the shark mouth pancreaticojejunostomy is a promising new technique for pancreaticoenteric reconstruction aimed at reducing the incidence of CR-POPF and other postoperative complications. The study is designed to evaluate its efficacy and safety, with the hope that it will become a widely accepted procedure in pancreaticoduodenectomy. Further studies are warranted to strengthen its therapeutic value and confirm its benefits in a broader patient population.

doi.org/10.1097/CM9.0000000000000219

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