Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

NCT ID: NCT04663789

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-05-30

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.

Conditions

Pancreas Neoplasm; Stump; Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Staple line plus reinforcement

In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.

Group Type: EXPERIMENTAL

reinforcement of the staple line

Intervention Type: PROCEDURE

The operator will perform reinforcement of the staple line with a continuous lock stitch.

staple line with no reinforcement

In this control group, no additional reinforcement is used after transecting the pancreas with stapler.

Group Type: OTHER

staple only

Intervention Type: PROCEDURE

The operator transect the pancreas with stapler only, without staple line reinforcement.

Interventions

reinforcement of the staple line

The operator will perform reinforcement of the staple line with a continuous lock stitch.

Intervention Type: PROCEDURE

staple only

The operator transect the pancreas with stapler only, without staple line reinforcement.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Feng Tian

Attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junchao Guo, Doctor

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Tian, Doctor

Role: CONTACT

andytianfeng@126.com

+86-01069152600

Jun Lu, Doctor

Role: CONTACT

pumchtf@sina.com

+86-01069152601

Facility Contacts

Feng Tian, Doctor

Role: primary

andytianfeng@126.com

Other Identifiers

PUMCHTF2

Identifier Type: -

Identifier Source: org_study_id