Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Surgery--Complications Clinical Trial

— Double-Lock  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663789
• Other study ID #: PUMCHTF2
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2021
• Source: Peking Union Medical College Hospital
• Contact: Feng Tian, Doctor
• Phone: +86-01069152600
• Email: andytianfeng[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: May 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Neoplasm
• Pancreatic Fistula
• Pancreatic Neoplasms
• Stump
• Surgery--Complications

Intervention

Procedure:
• reinforcement of the staple line
The operator will perform reinforcement of the staple line with a continuous lock stitch.
• staple only
The operator transect the pancreas with stapler only, without staple line reinforcement.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	Skin-to-skin time	Postoperative postoperative day 30.
Secondary	Estimated blood loss	Total blood loss during surgery	Postoperative postoperative day 30.
Secondary	Length of postoperative hospital stay	Days of hospital stay after surgery	Postoperative postoperative day 30.