RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04037982

Collaborator

(none)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.

Condition or Disease	Intervention/Treatment	Phase
Periampullary Tumor Complication Death Survival	Procedure: laparoscopic pancreaticoduodenectomy Procedure: Open pancreaticoduodenectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LPD In this group, patients will undergo laparoscopic pancreaticoduodenectomy.	Procedure: laparoscopic pancreaticoduodenectomy During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.
Active Comparator: OPD In this group, patients will undergo open pancreaticoduodenectomy.	Procedure: Open pancreaticoduodenectomy During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.

Arm

Intervention/Treatment

Experimental: LPD

In this group, patients will undergo laparoscopic pancreaticoduodenectomy.

Procedure: laparoscopic pancreaticoduodenectomy

During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.

Active Comparator: OPD

In this group, patients will undergo open pancreaticoduodenectomy.

Procedure: Open pancreaticoduodenectomy

During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.

Outcome Measures

Primary Outcome Measures

Incidence of complications [30 days after operation]
The patients number with complications / The total number in this group

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; Serum bilirubin was less than 100 μ mol/L before operation; Sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital, Capital medical University	Beijing		China

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhongtao Zhang, Chief Physician, Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT04037982

Other Study ID Numbers:

CR-LPD

First Posted:

Jul 30, 2019

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 30, 2019