Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy (Double-Lock)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications; Pancreas Neoplasm; Stump
• Intervention / Treatment: Procedure: reinforcement of the staple line; Procedure: staple only

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 Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Tian, Doctor; Phone Number: +86-01069152600; Email: andytianfeng@126.com
• Study Contact Backup: Name: Jun Lu, Doctor; Phone Number: +86-01069152601; Email: pumchtf@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Feng Tian, Doctor; Email: andytianfeng@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staple line plus reinforcement; In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.	Procedure: reinforcement of the staple line; The operator will perform reinforcement of the staple line with a continuous lock stitch.
Other: staple line with no reinforcement; In this control group, no additional reinforcement is used after transecting the pancreas with stapler.	Procedure: staple only; The operator transect the pancreas with stapler only, without staple line reinforcement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically relevant postoperative pancreatic fistula (CR-POPF)	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.	Postoperative postoperative day 30.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Junchao Guo, Doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatic fistula; Reinforcement; Staple line
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Pancreatic Fistula
• Other Study ID Numbers: PUMCHTF2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No