Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Not Applicable

• Conditions: Stump; Pancreas Neoplasm; Surgery--Complications
• Interventions: Procedure: staple only; Procedure: reinforcement of the staple line

• Registration Number: NCT04663789
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-24
• Study Start: 2020-12-01
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12
• Primary Completion: 2022-12-01
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant;
• Aged from 18 - 80 years;
• Preoperative diagnosis of serous or mucinous cystic adenoma;
• Preoperative diagnosis of solid pseudopapillary tumor (SPT);
• Preoperative diagnosis of neuroendocrine tumor;
• Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN);
• Preoperative diagnosis of or pseudocyst;
• Preoperative diagnosis of distal pancreatic malignancies;
• Patients willing to provide informed consent.

Exclusion Criteria

• History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy);
• Pancreatic trauma;
• With pneumoperitoneum contraindications;
• With severe heart or pulmonary diseases which is not fit for surgeries.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
staple line with no reinforcement	staple only	In this control group, no additional reinforcement is used after transecting the pancreas with stapler.
Staple line plus reinforcement	reinforcement of the staple line	In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.

Primary Outcome Measures

Name	Time	Method
Clinically relevant postoperative pancreatic fistula (CR-POPF)	Postoperative postoperative day 30.	CR-POPF is defined according to the revised 2016 version of ISGPS (International Study Group on Pancreatic Surgery) classification and grading of POPF. A CR-POPF is defined as a drain output of any measurable volume of fluid with amylase level greater than 3 times the upper Institutional normal serum amylase level, associated with a clinically relevant development/condition related directly to the POPF.

Secondary Outcome Measures

Name	Time	Method
Estimated blood loss	Postoperative postoperative day 30.	Total blood loss during surgery
Length of postoperative hospital stay	Postoperative postoperative day 30.	Days of hospital stay after surgery
Operative time	Postoperative postoperative day 30.	Skin-to-skin time

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China