NCT04663789

Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.

Detailed description

Distal pancreatectomy (DP)is the standard surgical method for benign or malignant pancreatic tumors locating at body and tail \[1\]. Clinically relevant postoperative pancreatic fistula (CR-POPF) is the major complication after pancreatectomy. In literature, reported CR-POPF rate after distal pancreatectomy varied between 5% and 64% from different centers. It's still a challenge to prevent CR-POPF via effective pancreatic remnant closure and no consensus on the optimal surgical technique has been established. Reported surgical strategies to prevent CR-POPF included stapler transection, staple line reinforcement, stump coverage with autologous tissue or fibrin glue, mesh reinforcement, and prophylactic administration of octreotide. However, none had convincing outcome \[2-4\]. Data has shown that staple line plus suture reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Meanwhile, prior researches have commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult \[5-8\]. Thus, the investigators design a single-centered, parallel, randomized controlled trial to compare the efficacy of routine staple line plus reinforcement versus staple only on the CR-POPF rate of participants who underwent minimally invasive distal pancreatectomies.

Conditions

• Pancreas Neoplasm
• Stump
• Surgery--Complications

Interventions

Type	Name	Description
PROCEDURE	reinforcement of the staple line	The operator will perform reinforcement of the staple line with a continuous lock stitch.
PROCEDURE	staple only	The operator transect the pancreas with stapler only, without staple line reinforcement.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2023-05-30
• First posted: 2020-12-11
• Last updated: 2021-02-12

Locations

1 site across 1 country: China